Tirapazamine Plus Cyclophosphamide in Treating Children With 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 tirapazamine plus cyclophosphamide in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Tirapazamine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor that is refractory to conventional therapy or for which no effective therapy is known

• Brain tumors eligible Brainstem gliomas may waive histological verification requirement

• Neurologic deficits associated with CNS malignancies must be stable for a minimum of 4 weeks prior to study

• No leukemia Stratum 2

• No marrow involvement

PATIENT CHARACTERISTICS:

• Age: 21 and under

• Performance status: Karnofsky or Lansky 50-100%

• Life expectancy: At least 8 weeks

• Absolute neutrophil count at least 1,000/mm3

• Platelet count at least 75,000/mm3

• Hemoglobin at least 9 g/dL

• Bilirubin less than 1.5 mg/dL

• SGPT less than 5 times normal

• Creatinine normal for age OR creatinine clearance at least 70 mL/min

• Shortening fraction at least 27% of normal OR ejection fraction greater than 50% of normal

• Not pregnant or nursing

• Negative pregnancy test required

PRIOR CONCURRENT THERAPY:

• No concurrent anticancer therapy

• At least 6 months since bone marrow transplant and no evidence of graft versus host disease

• At least 1 week since growth factors

• No concurrent granulocyte colony-stimulating factor

• Recovered from prior immunotherapy

• Stratum 2: No prior bone marrow transplantation (with or without total body irradiation)

• At least 6 weeks since prior nitrosourea

• At least 2 weeks since other prior myelosuppressive chemotherapy

• Dexamethasone must be a stable or decreasing dose for 2 weeks prior to study

• Recovered from prior chemotherapy

• Stratum 2: No more than 2 prior chemotherapy regimens

• At least 2 weeks since local palliative radiotherapy (small port)

• At least 6 months since prior substantial bone marrow radiation (e.g., cross- sectional radiotherapy [greater than 24 Gy], total body irradiation, hemi- pelvic radiotherapy)

• Recovered from prior radiotherapy

• Stratum 2: No prior central axis radiation