Pyroxamide in Treating Patients With Advanced Cancer
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.
PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
OBJECTIVES:
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Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies.
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Define, qualitatively and quantitatively, the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
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Describe the pharmacologic behavior of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for resolution of adverse events.
PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed solid tumor or hematologic malignancy
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Disease that has failed standard therapies (e.g., surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no curative or life- prolonging therapy is available
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Measurable or clinically evaluable disease
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Elevated tumor marker is acceptable for evaluable disease
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No known carcinomatous meningitis, primary brain tumors, or metastatic brain disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
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Absolute neutrophil count at least 1,500/mm^3
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Platelet count at least 125,000/mm^3
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Hemoglobin at least 9.0 g/dL
Hepatic
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Bilirubin normal
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AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
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PT no greater than 1.5 times ULN
Renal
- Creatinine normal
Other
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HIV-positive status allowed
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Prior malignancy allowed
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No severe physical or emotional illness that would preclude study participation
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent bone marrow growth factors
Chemotherapy
-
See Disease Characteristics
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At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
- See Disease Characteristics
Radiotherapy
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See Disease Characteristics
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At least 4 weeks since prior wide-field radiotherapy and recovered
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At least 2 weeks since prior limited-field radiotherapy and recovered
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Recovered from prior radiotherapy
Surgery
- See Disease Characteristics
Other
- No other concurrent antitumor treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Leonard B. Saltz, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 99-090
- CDR0000069483
- NCI-2110