Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer

NCT00003108 | Completed Phase 1

• 3 other identifiers: GUMC-97166CDR0000065849NCI-T97-0056
• Study Type: interventional
• Target: N/A
• 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of cisplatin plus bryostatin 1 in treating patients who have advanced cancer.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

bryostatin 1 DRUG

cisplatin DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed, incurable solid tumor that is unresectable or has distant metastasis for which a more effective therapy does not exist No active CNS metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Transaminases no greater than 2.5 times normal PT and PTT no greater than 1.25 times upper limit of normal Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within past 6 months No congestive heart failure or serious arrhythmias requiring treatment Other: No greater than grade 2 neuropathy (including hearing loss) No frequent vomiting or severe anorexia No recent loss of greater than 10% of body weight Not pregnant or nursing Fertile patients must use effective birth control during and for at least 6 months after study No serious concurrent medical illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered from toxic effects No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since prior mitomycin or nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy allowed if patient has progressive disease while receiving hormonal therapy for at least three months Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiation therapy Surgery: At least 21 days since prior major surgery Other: Any drugs that affect hepatic or renal function must be given as a stable dose and should not be initiated after patient enters study

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

Sponsors & Collaborators

• Lombardi Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Interventions

bryostatin 1; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• John L. Marshall, MD

  Lombardi Comprehensive Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: February 9, 2004
• Study Start: October 1, 1997
• Study Completion: October 1, 2007
• Last Updated: July 18, 2013

Record last verified: 2004-07

Locations

US (1)