Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer

August 13, 2020 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 116 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 1996

Primary Completion (Actual)

February 10, 2002

Study Completion (Actual)

February 10, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 25, 2004

First Posted (Estimate)

March 26, 2004

Study Record Updates

Last Update Posted (Actual)

August 17, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065420
  • YALE-HIC-9043 (Other Identifier: Yale Human Investigations Committee)
  • NCI-G97-1158 (Other Grant/Funding Number: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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