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Phase I/II Study of Topotecan (SKF 104864) With Recombinant GM-CSF (Sargramostim) Used as a Priming Agent in Advanced Malignancies

Phase 1/Phase 2
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I/II Study of Topotecan (SKF 104864) With Recombinant GM-CSF (Sargramostim) Used as a Priming Agent in Advanced Malignancies

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.

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven malignancy for which no alternative
treatment exists

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Thomas J. Rutherford, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University


United States: Federal Government

Study ID:




Start Date:

September 1996

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific



Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028