Bryostatin 1 Plus Paclitaxel and Cisplatin in Treating Patients With Advanced Solid Tumors

June 20, 2013 updated by: Memorial Sloan Kettering Cancer Center

An Open-Label, Non-Randomized Phase I Study of the Protein Kinase C Inhibitor Bryostatin-1 Administered in Combination With Paclitaxel in Patients With Advanced Solid Tumors

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 chemotherapy with bryostatin 1 plus paclitaxel and cisplatin in treating patients with advanced solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of intravenous bryostatin 1 when administered in combination with a fixed dose of paclitaxel and cisplatin in patients with advanced solid tumors. II. Investigate the clinical pharmacokinetics of intravenous paclitaxel when administered in combination with bryostatin 1 in these patients. III. Obtain preliminary data on the therapeutic activity of this therapy in these patients and evaluate surrogate markers of activity.

OUTLINE: This is an open label, dose escalation study. Patients receive paclitaxel IV over 1 hour on day 1. On day 2, patients receive bryostatin 1 IV over 1 hour immediately followed by cisplatin IV on day 2. Treatment is repeated weekly for 3 consecutive weeks followed by one week of rest for at least 2 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are entered at escalating dose levels of bryostatin 1 and paclitaxel. If 2 of 6 patients experience dose limiting toxicity (DLT) at any given dose level, then the maximum tolerated dose (MTD) is declared to be the preceding dose level. Once the MTD of paclitaxel and bryostatin 1 has been established, escalations of weekly cisplatin will be added. Additional patient cohorts receive two escalating doses of paclitaxel and cisplatin with the fixed bryostatin 1 dose level, in the absence of DLT. Patients at a lower bryostatin 1 dose may be escalated to a higher bryostatin 1 dose, only if that higher dose has been proven to be safe in another cohort of patients.

PROJECTED ACCRUAL: An anticipated 3 to 60 patients will be accrued for this study within 1-14 months.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor Must be refractory to standard therapy or no standard therapy exists No CNS metastases or CNS primary malignancy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No history of cardiac arrhythmias No congestive heart failure No myocardial infarction in the last 6 months Neurologic: No grade 3 or greater neurotoxicity Other: HIV negative No serious or uncontrolled infection Not pregnant Adequate contraception required of all fertile patients during study and until 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 6 weeks since prior nitrosoureas or mitomycin At least 4 weeks since other prior chemotherapy Must have recovered from prior chemotherapy Endocrine therapy: Must have recovered from prior endocrine therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1998

Primary Completion (ACTUAL)

October 1, 2001

Study Completion (ACTUAL)

October 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 15, 2004

First Posted (ESTIMATE)

June 16, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-139
  • CDR0000066117 (REGISTRY: PDQ (Physician Data Query))
  • NCI-T97-0118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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