Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, NSC #742460) in Children With Relapsed/Refractory Solid Tumors
Verified date | June 2014 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This phase I clinical trial is studying the side effects and best dose of IMC-A12 in treating young patients with relapsed or refractory Ewing sarcoma/peripheral primitive neuroectodermal tumor or other solid tumors. Monoclonal antibodies, such as IMC-A12, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
Status | Completed |
Enrollment | 34 |
Est. completion date | |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 21 Years |
Eligibility |
Inclusion Criteria: - Histologically confirmed solid tumor - Relapsed or refractory disease - No central nervous system (CNS) tumor or lymphoma - Histological confirmation may have been made at original diagnosis or at relapse - Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life - Measurable or evaluable disease - Patients with Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET) must have tissue blocks or slides available - Study chair must be notified if tissue blocks or slides are not available - Karnofsky performance status (PS) = 50% (patients > 10 years of age) and Lansky (PS) = 50% (patients = 10 years of age) - Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score - Creatinine clearance or radioisotope GFR = 70 mL/min OR serum creatinine based on age/gender as follows: - 1 to < 2 years (males and females 0.6 mg/dL) - 2 to < 6 years (males and females 0.8 mg/dL) - 6 to < 10 years (males and females 1.0 mg/dL) - 10 to < 13 years (males and females 1.2 mg/dL) - 13 to < 16 years (males 1.5 mg/dL and females 1.4 mg/dL) - = 16 years (males 1.7 mg/dL and females 1.4 mg/dL) - Bilirubin = 1.5 times upper limit of normal (ULN) for age - SGPT (ALT) = 110 µ/L (for the purpose of this study, the ULN for SGPT is 45 µ/L) - Serum albumin = 2 g/dL - Patients with known bone marrow metastatic disease will be eligible for study but not evaluable for hematologic toxicity - Patients must not be known to be refractory to red cell or platelet transfusion - Patients with solid tumors without bone marrow involvement must meet the following criteria: - Peripheral absolute neutrophil count = 1,000/µL - Platelet count = 100,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment) - Hemoglobin = 8.0 g/dL (may receive RBC transfusions) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after completion of study therapy - No uncontrolled infection - No known type I or type II diabetes mellitus - Able to comply with the safety monitoring requirements of the study, in the opinion of the investigator - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12 - Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study - At least 7 days since prior and no concurrent hematopoietic growth factors - Growth factors that support platelet or white cell number or function can only be administered for culture-proven bacteremia or invasive fungal infection - At least 7 days since prior and no concurrent biologic antineoplastic agents - At least 6 weeks since prior monoclonal antibodies - At least 3 months since prior total body irradiation (TBI), craniospinal external radiotherapy (XRT), or = 50% radiotherapy to the pelvis - At least 2 weeks since prior local XRT (small port) - At least 6 weeks since other prior substantial bone marrow radiotherapy - More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) - More than 7 days since prior and no concurrent systemic corticosteroids - Prior stem cell transplant or rescue allowed provided there has been no evidence of active graft-versus-host-disease within the past 2 months - No prior monoclonal antibody therapy targeting the IGF-IR - No concurrent chemotherapy, radiotherapy, or immunotherapy - No concurrent anticancer agents - No concurrent insulin or growth hormone therapy - No other concurrent investigational drugs |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | COG Phase I Consortium | Arcadia | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 | Toxicity tables will be constructed to summarize the observed incidence by severity and type of toxicity. | Weekly during each course | Yes |
Primary | MTD or recommended phase II dose | MTD will be the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT). DLT is defined as any hematological and non-hematological toxicities that is possible, probably, or definitely attributed to IMC-A12. | During course 1 | Yes |
Primary | Pharmacokinetics of IMC-A12 | At baseline, days 1, 8, 15, 22, and 28 of course 1, and days 15 and 28 of course 2 | No | |
Secondary | Response rate (complete or partial response) in patients with Ewing sarcoma/peripheral PNET | Confidence intervals will be constructed according to the method of Chang and O'Brien to account for the two-stage design. | Up to 30 days after completion of treatment | No |
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