Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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. 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Dexrazoxane; Doxorubicin; Liposomal doxorubicin; Oblimersen; Razoxane

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor at original diagnosis that has failed standard therapy or for which no standard therapy exists

• Patients must have a disease for which there is no known curative potential

• Patients must meet the following criteria for bone marrow function:

• Status post stem cell transplantation (SCT)

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3 (transfusion independent)

• Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)

• No lymphomas

• No CNS tumors or known metastatic disease to the brain or spinal cord

• Performance status - Karnofsky 50-100% (age 11 to 21)

• Performance status - Lansky 50-100% (age 1 to 10)

• At least 8 weeks

• See Disease Characteristics

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• ALT no greater than 3 times ULN

• No significant hepatic dysfunction

• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

• Creatinine, based on age, as follows:

• Age 1 to 5: no greater than 0.8 mg/dL

• Age 6 to 10: no greater than 1.0 mg/dL

• Age 11 to 15: no greater than 1.2 mg/dL

• Age 16 to 21: no greater than 1.5 mg/dL

• No significant renal dysfunction

• Shortening fraction at least 28% by echocardiogram

• Ejection fraction at least 45% by MUGA

• No significant pulmonary dysfunction

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No serious uncontrolled infections

• No other end-organ dysfunction that would preclude study entry

• No other clinically significant systemic illness

• See Disease Characteristics

• Recovered from prior immunotherapy

• At least 1 week since prior growth factors or other biologic agents

• At least 6 months since prior autologous SCT

• At least 6 months since prior allogeneic bone marrow transplantation and recovered with no evidence of graft-versus-host disease

• No concurrent immunomodulating agents

• No concurrent prophylactic growth factors during the first course of the study

• No concurrent immunotherapy or other biologic therapy

• Recovered from prior chemotherapy

• At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)

• No prior life-time cumulative doxorubicin dose of more than 450 mg/m^2 or equivalent

• No other concurrent chemotherapy

• Concurrent chronic steroids allowed

• Recovered from prior radiotherapy

• More than 2 weeks since prior localized palliative radiotherapy (small port)

• More than 6 months since prior substantial radiotherapy to bone marrow (craniospinal radiotherapy, total body irradiation, or hemi-pelvic radiotherapy)

• No concurrent radiotherapy

• Concurrent chronic medications (e.g., narcotics or antiepileptics) allowed

• No other concurrent investigational agents

• No other concurrent cancer therapy