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



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

For Condition: chronic myeloproliferative disorders,plasma cell neoplasm,myelodysplastic and myeloproliferative diseases,Leukemia,Lymphoma
Status: Recruiting
Sponsor(s): Cancer Institute of New Jersey , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of 12-O-tetradecanoylphorbol-13-acetate in treating patients who have hematologic cancer or bone marrow disorder that has not responded to previous treatment.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RogerStrair,  Study Chair,  Cancer Institute of New Jersey

Cancer Institute of New Jersey *Recruiting*
New Brunswick,  New Jersey,  08901
United States
Recruiting Roger  Strair 732-235-6044


Additional Information:
Study ID Numbers:
  CDR0000067255;  CINJ-059806,UMDNJ-2716,NCI-G99-1573
Study Start Date: 
Record last reviewed: November 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004058

Other Leukemia Studies:
1. Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies

2. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders

3. Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

4. Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder

5. Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies

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