NCT00002950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 1996

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

March 26, 2004

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

5.4 years

First QC Date

November 1, 1999

Last Update Submit

August 13, 2020

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

sargramostimBIOLOGICAL
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

MeSH Terms

Interventions

sargramostimTopotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Thomas J. Rutherford, MD, PhD

    Yale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 26, 2004

Study Start

September 26, 1996

Primary Completion

February 10, 2002

Study Completion

February 10, 2002

Last Updated

August 17, 2020

Record last verified: 2020-08

Locations

US(1)