RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of topotecan plus sargramostim in treating patients who have advanced cancer.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: sargramostim  Drug: topotecan	Phase I Phase II

Further Study Details: 

OBJECTIVES: I. Identify a priming schedule of sargramostim (GM-CSF) that reduces the percentage of progenitor cells in cycle at the time of chemotherapy administration in patients with advanced malignancies. II. Determine the maximum tolerated dose and toxic effects of topotecan when administered with sargramostim in these patients. III. Conduct a preliminary assessment of the activity of this topotecan regimen in these patients.

PROTOCOL OUTLINE: This is a dose escalation study of topotecan. Patients receive priming with sargramostim (GM-CSF) on days -4 through -2. On day 0, topotecan IV is administered over 30 minutes. Cohorts of 6 patients receive escalating doses of topotecan. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT). Sargramostim resumes on day 1 following topotecan, and continues for 5 days or until sufficient hematologic recovery. The next course of topotecan is given 48 hours later. Treatment repeats every 6 weeks for 4 courses. Patients are followed every 3 months for the first year, then every 6 months thereafter.

PROJECTED ACCRUAL: 15-25 patients will be accrued for the duration of 18 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven malignancy for which no alternative treatment exists

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• Endocrine therapy: Not specified
• Radiotherapy: No prior wide field radiotherapy; No prior radiotherapy to greater than 20% of bone marrow
• Surgery: Recovered from prior surgery

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: At least 3 months
• Hematopoietic: Platelet count at least 100,000/mm3; Absolute neutrophil count at least 1500/mm3
• Hepatic: Total bilirubin no greater than 2.0 mg/dL
• Renal: Creatinine clearance at least 50 mL/min
• Other: No active infections; HIV negative; No other concurrent medical condition

Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States

Study chairs or principal investigators

Thomas J. Rutherford,  Study Chair,  Yale Cancer Center   

Study ID Numbers:  CDR0000065420; YALE-HIC-9043; NCI-G97-1158
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002950
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08