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A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies


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

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Trial Information

A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies


OBJECTIVES:

- Determine the maximum tolerated dose, toxicities, and preliminary antitumor activity of
escalating doses of topotecan, with filgrastim (G-CSF) and peripheral blood stem cell
support, when administered to patients with refractory malignancies for which no
effective therapy exists.

OUTLINE: This is a dose-escalation study.

Prior to stem cell harvesting, patients receive 1-2 courses of mobilizing salvage
chemotherapy.

After stem cell harvest, high-dose topotecan is administered according to an escalating
dosage scale. Topotecan is given over 30 minutes daily for three days. A minimum of 3
patients are entered at each dose level. The MTD is defined as the dose immediately below
that at which 2 patients experience dose limiting toxicity.

Peripheral blood stem cells (PBSC) are infused at least 24 hours after treatment with
topotecan is complete. Filgrastim (G-CSF) is administered subcutaneously beginning on the
day PBSC are infused and continuing until blood counts recover.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: Not specified

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed refractory malignancies for which no effective therapy is
currently available

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Platelet count at least 100,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

Hepatic:

- Total bilirubin no greater than 2.0 mg/dL

- No chronic active hepatitis

Renal:

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- Left ventricular ejection fraction greater than 45%

Pulmonary:

- DLCO greater than 60% of predicted

Other:

- HIV negative

- No active infection

- No concurrent medical condition that would preclude therapy

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or
mitomycin)

Endocrine therapy:

- Not specified

Radiotherapy:

- No radiotherapy to greater than 30% of bone marrow

- No wide field radiotherapy

Surgery:

- Recovered from any prior surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mario Sznol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University

Authority:

United States: Federal Government

Study ID:

CDR0000065416

NCT ID:

NCT00002948

Start Date:

October 1996

Completion Date:

Related Keywords:

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

Name

Location

Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028