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An Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP) in Cancer Patients Using a Single Daily Dose for Five Days


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

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Trial Information

An Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP) in Cancer Patients Using a Single Daily Dose for Five Days


OBJECTIVES: I. Determine the effects of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone
(3-AP) in patients with solid tumors by evaluating the safety and tolerability, maximum
tolerated dose (MTD) and recommended dose for Phase II studies, pharmacokinetics, and tumor
response.

OUTLINE: This is a dose escalation study. Patients receive 3-aminopyridine-2-carboxaldehyde
thiosemicarbazone (3-AP) IV over 2 hours on days 1-5. Treatment repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive
escalating doses of 3-AP 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. Patients are followed for 4 weeks or until recovered.

PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor that has failed 1
or more conventional treatments or is unlikely to respond to currently available therapies
No active CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 3 months Hematopoietic: WBC greater than 3,000/mm3 Absolute
neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin at
least 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL AST and ALT no greater than 3 times
upper limit of normal (ULN) Alkaline phosphate no greater than 3 times ULN (no greater
than 5 times ULN if liver metastases present) Renal: Creatinine less than 2.0 mg/dL
Cardiovascular: No myocardial infarction within the past 3 months No symptomatic coronary
artery disease or heart block No uncontrolled congestive heart failure Pulmonary: No
moderate or severe pulmonary dysfunction Other: Not pregnant or nursing Negative pregnancy
test Fertile women must use effective contraception Body weight greater than 50 kg No
active infection No mental deficits and/or psychiatric disorders that would preclude study
No other life-threatening illness No bleeding disorder (except occult blood from
gastrointestinal cancer)

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior growth factor treatment allowed if blood
counts normal Chemotherapy: At least 3 weeks since prior chemotherapy and recovered At
least 6 weeks since prior nitrosoureas or mitomycin and recovered Prior hydroxyurea
allowed and recovered Endocrine therapy: At least 2 weeks since prior hormonal therapy
Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior
radiotherapy to greater than 30% of the bone marrow Surgery: At least 2 weeks since any
prior major surgery Other: At least 4 weeks since other prior investigational agents and
recovered No other concurrent investigational agents without consent of sponsor

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:

CDR0000067390

NCT ID:

NCT00004213

Start Date:

May 1998

Completion Date:

Related Keywords:

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

Name

Location

Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Arizona Clinical Research CenterTucson, Arizona  85712