12-O-Tetradecanoylphorbol-13-acetate in Treating Patients With Hematologic Cancer or Bone Marrow Disorder

Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders

Sponsors

Lead Sponsor: University of Medicine and Dentistry of New Jersey

Collaborator: National Cancer Institute (NCI)

Source Rutgers, The State University of New Jersey
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of 12-O-tetradecanoylphorbol-13-acetate in treating patients with hematologic cancer or bone marrow disorder that has not responded to previous treatment.

Detailed Description

OBJECTIVES:

- Determine the maximum tolerated dose and dose limiting toxicity of 12-O-tetradecanoylphorbol-13-acetate (TPA) in patients with relapsed or refractory hematologic malignancies or bone marrow disorders.

- Determine the pharmacokinetics of TPA in these patients.

- Determine the effects of TPA on the cellular composition of blood and bone marrow in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive 12-O-tetradecanoylphorbol-13-acetate (TPA) IV over 1 hour on days 1 and 8 followed by 2 weeks of rest. Courses repeat in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of TPA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study.

Overall Status Terminated
Start Date December 1998
Completion Date November 2004
Primary Completion Date November 2004
Phase Phase 1
Study Type Interventional
Condition
Intervention

Intervention Type: Drug

Intervention Name: tetradecanoylphorbol acetate

Eligibility

Criteria:

DISEASE CHARACTERISTICS:

- Histologically proven relapsed or refractory hematologic malignancy or bone marrow disorder for which there is no standard curative therapy, including, but not limited to:

- Myelodysplasia

- Multiple myeloma

- Myeloproliferative syndrome

- Chronic lymphocytic leukemia

- Aplastic anemia

- Non-Hodgkin's lymphoma

- Acute leukemia

- Hodgkin's lymphoma

- Chronic myelogenous leukemia

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-2

Life expectancy:

- Greater than 1 month

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST no greater than 3 times ULN

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- Cardiac ejection fraction greater than 40%

Pulmonary:

- FEV_1 greater than 50% predicted

Other:

- No active infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 10 weeks after study participation

- No uncontrolled psychiatric or medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Greater than 3 weeks since prior biologic therapy

Chemotherapy:

- Greater than 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No other concurrent investigational agents

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Roger Strair, MD, PhD Study Chair Rutgers Cancer Institute of New Jersey
Location
Facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Location Countries

United States

Verification Date

January 2010

Responsible Party

Name Title: Roger Strair, MD, PhD

Organization: UMDNJ/CINJ

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary Purpose: Treatment

Source: ClinicalTrials.gov