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A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Cancer Patients Using a 96-Hour Intravenous Continuous Infusion


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) in Cancer Patients Using a 96-Hour Intravenous Continuous Infusion


OBJECTIVES: I. Determine the safety, tolerability, and toxicity of 3-AP in patients with
advanced malignancies. II. Determine the maximum tolerated dose and recommended phase II
dose of this treatment in these patients. III. Determine the pharmacokinetic parameters of
this treatment in these patients. IV. Determine the tumor response in these patients treated
with this regimen.

OUTLINE: This is a dose escalation, multicenter study. Patients receive 3-AP IV continuously
over 96 hours. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity. Patients with complete response receive treatment for 1 course past
the course in which the complete response was documented; patients with partial response may
receive treatment for up to 1 year; and patients with stable disease may receive treatment
for up to 6 months. During the accelerated phase of the study, cohorts of 1 patient each
receive escalating doses of 3-AP until one patient experiences dose limiting toxicity (DLT)
or 2 different patients experience grade 2 toxicity during any course. When the accelerated
phase ends, cohorts of 3-6 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 DLT.

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

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic malignancy Failed
one or more prior standard therapies or considered unlikely to respond to any currently
available therapy Measurable or evaluable disease No active, untreated CNS metastases
(stable for at least 2 months and no evidence of new CNS metastases)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) No bleeding
disorder (except occult blood for gastrointestinal cancers) Hepatic: Bilirubin no greater
than 2.0 mg/dL ALT, AST, and alkaline phosphatase no greater than 3 times upper limit of
normal (ULN) (no greater than 5 times ULN with liver metastases) PT and PTT no greater
than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active
heart disease No myocardial infarction within the past 3 months No symptomatic coronary
artery disease or heart block No uncontrolled congestive heart failure Pulmonary: No
moderate to severe compromise of pulmonary function Other: No active infection No mental
deficits and/or psychiatric history that would preclude study No other concurrent life
threatening illness Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception during and for 18 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks
since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No
persistent chronic toxicity from prior chemotherapy greater than grade 1 Endocrine
therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Concurrent
radiotherapy to single site of progressive disease allowed during first course of study
treatment Surgery: Not specified Other: At least 3 weeks since any prior treatment for
malignancy and recovered No other concurrent investigational drug

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:

CDR0000068067

NCT ID:

NCT00006218

Start Date:

May 2000

Completion Date:

Related Keywords:

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

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461