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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039481 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and cyclophosphamide by making the tumor cells more sensitive to the drug. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of oblimersen plus combination chemotherapy and dexrazoxane in treating children and adolescents who have relapsed or refractory solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Toxicity Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: filgrastim Biological: oblimersen sodium Drug: cyclophosphamide Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Trial Of G3139 (BCL-2 Antisense, NSC# 683428, IND# 58842) Combined With Cytotoxic Chemotherapy In Relapsed Childhood Solid Tumors |
| Study Start Date: | November 2002 |
OBJECTIVES:
OUTLINE: This is a 2-part, multicenter, dose-escalation study.
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Cohorts of 3-6 patients receive escalating doses of dexrazoxane, doxorubicin, and cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study within 1-2 years.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor at original diagnosis that has failed standard therapy or for which no standard therapy exists
Patients must meet the following criteria for bone marrow function:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Creatinine, based on age, as follows:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 22 Study Locations| Study Chair: | Susan Rheingold, MD | Children's Hospital of Philadelphia |
More Information
| Study ID Numbers: | CDR0000069387, COG-ADVL0211, NCI-03-C-0202 |
| Study First Received: | June 6, 2002 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00039481 History of Changes |
| Health Authority: | United States: Federal Government |
|
cardiac toxicity unspecified childhood solid tumor, protocol specific |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cardiovascular Agents Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Razoxane Neoplasms Therapeutic Uses Myeloablative Agonists Chelating Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |