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A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin


OBJECTIVES:

- Determine the maximum tolerated dose of cisplatin when administered with 3-AP in
patients with advanced cancer.

- Determine the toxic effects of this regimen in these patients.

- Determine the antitumor responses in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of cisplatin.

Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and
3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable
toxicity.

Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed progressive malignant disease that has failed at least 1
conventional treatment or is unlikely to respond to current therapy

- Measurable or evaluable disease

- Elevated serum tumor marker considered evaluable disease

- No known active CNS metastases

- Previously treated CNS metastases with no evidence of new CNS metastases allowed
if stable for at least 2 months

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

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

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

- Hemoglobin at least 10 g/dL (transfusion allowed)

- No active bleeding or coagulation disorder (except occult blood related to
gastrointestinal cancer)

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- ALT and AST no greater than 3 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 5 times ULN

- PT and PTT no greater than 1.5 times ULN

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No active heart disease

- No myocardial infarction within the past 3 months

- No symptomatic coronary artery disease

- No uncontrolled arrhythmias

- No uncontrolled congestive heart failure

Pulmonary:

- No moderate to severe compromise of pulmonary function

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infectious process

- No pre-existing severe hearing impairment

- No grade 2 or greater neuropathy

- No other life threatening illness

- No prior severe allergic reaction to cisplatin

- No mental deficits and/or psychiatric history that would preclude study

- No persistent chronic toxic effects from prior chemotherapy greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 2 weeks since prior biologic therapy

Chemotherapy:

- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered

- At least 3 months since prior cisplatin or platinum analogue

- No prior 3-AP

Endocrine therapy:

- At least 2 weeks since prior hormonal therapy

Radiotherapy:

- More than 3 weeks since prior radiotherapy

Surgery:

- At least 3 weeks since prior major surgery and recovered

Other:

- No other concurrent investigational drugs

- No other concurrent nephrotoxic drugs (e.g., aminoglycoside antibiotics)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mario Sznol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vion Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000068918

NCT ID:

NCT00024323

Start Date:

March 2001

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
Arizona Clinical Research CenterTucson, Arizona  85712