Clinical Trials
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-Lly
Lead Researcher: Angela R Girvin
Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab.
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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Palbociclib in Patients With Tumors Harboring Activating Alterations in Cell Cycle Genes,NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Palbociclib in Patients With Tumors Harboring Activating Alterations in Cell Cycle Genes,NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Palbociclib in Patients With Tumors Harboring Activating Alterations in Cell Cycle Genes
Lead Researcher: Angela R Girvin
This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients
with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating
alterations (mutations) in cell cycle genes that have spread to other places in the body and
have come back or do not respond to treatment. Palbociclib may stop the growth of cancer
cells by blocking some of the enzymes needed for cell growth.
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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of JNJ-42756493 (Erdafitinib) in Patients With Tumors Harboring FGFR1/2/3/4 Alterations,NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of JNJ-42756493 (Erdafitinib) in Patients With Tumors Harboring FGFR1/2/3/4 Alterations,NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of JNJ-42756493 (Erdafitinib) in Patients With Tumors Harboring FGFR1/2/3/4 Alterations
Lead Researcher: Angela R Girvin
This phase II Pediatric MATCH trial studies how well erdafitinib works in treating patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other
places in the body and have come back or do not respond to treatment with FGFR mutations.
Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for
cell growth.
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A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients
Lead Researcher: Angela R Girvin
This phase II trial studies how well reduced doses of radiation therapy to the brain and
spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of
brain tumor called WNT/Wingless (WNT)-driven medulloblastoma. Recent studies using
chemotherapy and radiation therapy have been shown to be effective in treating patients with
WNT-driven medulloblastoma. However, there is a concern about the late side effects of
treatment, such as learning difficulties, lower amounts of hormones, or other problems in
performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill
cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine
sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor
cells and may also reduce the late side effects of treatment.
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International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
Lead Researcher: Angela R Girvin
This randomized phase III trial studies how well imatinib mesylate and combination
chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive
acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by
blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in
different ways to stop the growth of cancer cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Giving imatinib mesylate and
combination chemotherapy may work better in treating patients with Philadelphia chromosome
positive acute lymphoblastic leukemia.
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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Ensartinib in Patients With Tumors Harboring ALK or ROS1 Genomic Alterations,NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Ensartinib in Patients With Tumors Harboring ALK or ROS1 Genomic Alterations
Lead Researcher: Angela R Girvin
This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic
alterations that have come back or do not respond to treatment and have spread to other
places in the body. Ensartinib may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth.
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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-101 (Larotrectinib) in Patients With Tumors Harboring Actionable NTRK Fusions
Lead Researcher: Angela R Girvin
This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have
spread to other places in the body and have come back or do not respond to treatment.
Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for
cell growth.
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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Selumetinib (AZD6244 Hydrogen Sulfate) in Patients With Tumors Harboring Activating MAPK Pathway Mutations,NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Selumetinib (AZD6244 Hydrogen Sulfate) in Patients With Tumors Harboring Activating MAPK Pathway Mutations
Lead Researcher: Angela R Girvin
This phase II Pediatric MATCH trial studies how well selumetinib works in treating patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway
activation mutations that have spread to other places in the body and have come back or do
not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking some of
the enzymes needed for cell growth.
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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol
Lead Researcher: Angela R Girvin
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment
that is directed by genetic testing works in pediatric patients with solid tumors,
non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one
line of standard systemic therapy and/or for which no standard treatment exists that has been
shown to prolong survival. Genetic tests look at the unique genetic material (genes) of
patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit
more from treatment which targets their tumor's particular genetic mutation, and may help
doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.
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A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors
Lead Researcher: Angela R Girvin
This partially randomized phase III trial studies how well active surveillance, bleomycin,
carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ
cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell
tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin,
carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading.
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A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia
Lead Researcher: Angela R Girvin
This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent
chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the
study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy
regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the
recommended dose determined in Part 1.
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Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
Lead Researcher: Angela R Girvin
This phase III trial studies response-based chemotherapy in treating newly diagnosed acute
myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs
used in chemotherapy work in different ways to stop the growth of cancer cells, either by
killing the cells, by stopping them from dividing, or by stopping them from spreading.
Response-based chemotherapy separates patients into different risk groups and treats them
according to how they respond to the first course of treatment (Induction I). Response-based
treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in
younger patients with Down syndrome while reducing the side effects.
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The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
Lead Researcher: Angela R Girvin
This research trial studies the Project: Every Child for younger patients with cancer.
Gathering health information over time from younger patients with cancer may help doctors
find better methods of treatment and on-going care.
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Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL),Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL),Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
Lead Researcher: Angela R Girvin
This randomized phase III trial studies how well blinatumomab works compared with standard
combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that
has returned after a period of improvement (relapsed). Monoclonal antibodies, such as
blinatumomab, may interfere with the ability of tumor cells to grow and spread. It is not yet
known whether standard combination chemotherapy is more effective than blinatumomab in
treating relapsed B-cell acute lymphoblastic leukemia.
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Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients With Non-High-Risk Neuroblastoma,Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients With Non-High-Risk Neuroblastoma
Lead Researcher: Angela R Girvin
This phase III trial studies how well response and biology-based risk factor-guided therapy
works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may
not need treatment until it progresses. In this case, observation may be sufficient.
Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and
what the best treatment is. Response and biology-based risk factor-guided therapy may be
effective in treating patients with non-high risk neuroblastoma and may help to avoid some of
the risks and side effects related to standard treatment.
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Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy,Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy
Lead Researcher: Angela R Girvin
This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated
with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in
the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more
about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand
how well patients respond to treatment.
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Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years
Lead Researcher: Angela R Girvin
This partially randomized phase III trial is studying maintenance chemotherapy to see how
well it works compared to observation following induction chemotherapy and radiation therapy
in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such
as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in
different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Giving more than one drug
(combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy
x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of
radiation directly to the tumor may kill more tumor cells and cause less damage to normal
tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow
doctors to save the part of the body where the cancer started.
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Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer
Lead Researcher: Angela R Girvin
This research trial studies neuropsychological (learning, remembering or thinking) and
behavioral testing in younger patients with cancer. Collecting information over time from a
series of tests may help doctors develop effective tests to measure neuropsychological and
behavioral function of patients with cancer.
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Neuroblastoma Biology Studies,Neuroblastoma Biology Studies,Neuroblastoma Biology Studies
Lead Researcher: Angela R Girvin
This research trial studies biomarkers in tumor tissue samples from patients with newly
diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from
patients with cancer in the laboratory may help doctors identify and learn more about
biomarkers related to cancer.
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