Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed Over 18 NCI CINJ-059806 UMDNJ-2716, NCI-G99-1573, NCT00004058

Objectives

1. 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.
2. Determine the pharmacokinetics of TPA in these patients.
3. Determine the effects of TPA on the cellular composition of blood and bone marrow in these patients.

Entry 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

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

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:

• FEV₁ 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

Expected Enrollment

Approximately 36 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Roger Strair, MD, PhD, Protocol chair		Ph: 732-235-6044 Email: strairrk@umdnj.edu

Registry Information
Official Title		Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients with Refractory Hematologic Malignancies/Bone Marrow Disorders
Trial Start Date		1998-12-14
Registered in ClinicalTrials.gov		NCT00004058
Date Submitted to PDQ		1999-08-05
Information Last Verified		2007-10-19
NCI Grant/Contract Number		CA72720

Back to Top