3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors

NCT00004213 | Completed Phase 1

• 3 other identifiers: VION-CLI-001-2CDR0000067390NCI-V99-1579
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

triapine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vion Pharmaceuticals: lead

Study Sites (2)

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

MeSH Terms

Interventions

3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Study Officials

• Mario Sznol, MD

  Vion Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: May 3, 2004
• Study Start: May 1, 1998
• Study Completion: January 1, 2008
• Last Updated: July 18, 2013

Record last verified: 2007-12

Locations

US (2)