Anhydrovinblastine in Treating Patients With Advanced Recurrent Solid Tumors

NCT00003882 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000067049RPCI-DS-9844
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 anhydrovinblastine in treating patients who have advanced recurrent solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

anhydrovinblastine DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor unresponsive to existing therapy and for which no curative therapy exists No hematologic malignancies PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN (except with bone metastases) PT and PTT no greater than ULN Bilirubin no greater than ULN Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No congestive heart failure, angina pectoris (even if medically controlled), uncontrolled hypertension, arrhythmias, elevated CPK or recent EKG changes At least one year since myocardial infarction Neurologic: No history of neurologic or psychiatric disorders (e.g., dementia, seizures) No concurrent peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection No active pancreatitis Amylase no greater than the upper limit of normal No other serious systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent immunotherapy No concurrent colony stimulating factors (unless evidence of neutropenic infection) Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) Prior taxanes and vinca alkaloids allowed with recovery (excluding alopecia any grade and peripheral neuropathy no greater than grade 1) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered At least 6 weeks since prior extensive radiotherapy to greater than 20% of bone marrow No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental drugs At least 30 days since other investigational drug

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (1)

• Schwartz GN, Bong D, Leichman CG, et al.: Phase I evaluation of anhydrovinblastine in patients with advanced malignancies. [Abstract] Proc Am Assoc Cancer Res 41: 3895a, 2000.

  RESULT

Study Officials

• Nithya Ramnath, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2004
• Study Start: March 1, 1999
• Primary Completion: April 1, 2000
• Study Completion: September 1, 2000
• Last Updated: March 7, 2011

Record last verified: 2011-03

Locations

US (1)