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

Tracking Information

First Received Date ^ICMJE

December 10, 1999

Last Updated Date

November 12, 2009

Start Date ^ICMJE

December 1998

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004058 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Precancerous/Nonmalignant Condition

Intervention ^ICMJE

Drug: tetradecanoylphorbol acetate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2004

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004058

Responsible Party

Roger Strair, MD, PhD, UMDNJ/CINJ

Study ID Numbers ^ICMJE

CDR0000067255, P30CA072720, CINJ-059806, UMDNJ-2716, NCI-G99-1573

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Roger Strair, MD, PhD

Cancer Institute of New Jersey

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP