Full Text View
Tabular View
No Study Results Posted
Related Studies
3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors
This study has been completed.

First Received on January 28, 2000.   Last Updated on July 23, 2008   History of Changes
Sponsor: Vion Pharmaceuticals
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004213
  Purpose

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 3-aminopyridine-2-carboxaldehyde thiosemicarbazone in treating patients who have solid tumors that have not responded to previous treatment.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: triapine
Phase I

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 1998
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004213

Locations
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
Sponsors and Collaborators
Vion Pharmaceuticals
Investigators
Study Chair: Mario Sznol, MD Vion Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004213     History of Changes
Other Study ID Numbers: CDR0000067390, VION-CLI-001-2, NCI-V99-1579
Study First Received: January 28, 2000
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012