Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT00002950
Collaborator
National Cancer Institute (NCI) (NIH)
25
1
64.5
0.4

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Biological: sargramostim
  • Drug: topotecan hydrochloride
Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of Topotecan (SKF 104864) With Recombinant GM-CSF (Sargramostim) Used as a Priming Agent in Advanced Malignancies
Actual Study Start Date :
Sep 26, 1996
Actual Primary Completion Date :
Feb 10, 2002
Actual Study Completion Date :
Feb 10, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale Comprehensive Cancer Center New Haven Connecticut United States 06520-8028

    Sponsors and Collaborators

    • Yale University
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Thomas J. Rutherford, MD, PhD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT00002950
    Other Study ID Numbers:
    • CDR0000065420
    • YALE-HIC-9043
    • NCI-G97-1158
    First Posted:
    Mar 26, 2004
    Last Update Posted:
    Aug 17, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by Yale University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2020