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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021359 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma.
PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: dexamethasone Drug: isotretinoin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Dexamethasone and 13-Cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma |
Study Start Date: | August 1999 |
OBJECTIVES: I. Determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin. II. Determine the toxicity of this regimen in these patients. III. Correlate the changes in serum interleukin (IL)-6, IL-6R, and C-reactive and IL-6R expression on plasma cells in the bone marrow with response in patients treated with this regimen.
OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral isotretinoin daily. Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression, insufficient response, or unacceptable toxicity. Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein, for a minimum of 6 courses total.
PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Elevated monoclonal protein in serum and/or urine
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3* Platelet count at least 75,000/mm3* *Unless secondary to multiple myeloma involvement of the bone marrow Hepatic: Bilirubin less than 1.5 mg/dL Transaminase less than 2 times normal Renal: Creatinine less than 2.0 mg/dL No overt renal insufficiency Cardiovascular: No congestive heart failure No myocardial infarction within the past 6 months No significant arrhythmia or poorly controlled hypertension Pulmonary: No severe pulmonary disease Other: Triglycerides normal No other severe medical illness No active peptic ulcer disease No brittle insulin-dependent diabetes No severe depression or other psychiatric illness No active infection No history of severe ethanol or drug abuse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior palliative radiotherapy allowed Surgery: At least 3 weeks since prior major surgery
United States, New Jersey | |
Community Medical Center | |
Toms River, New Jersey, United States, 08755 | |
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | |
Mount Holly, New Jersey, United States, 08060 | |
Hunterdon Regional Cancer Center | |
Flemington, New Jersey, United States, 08822 | |
St. Francis Medical Center | |
Trenton, New Jersey, United States, 08629 | |
Riverview Medical Center - Booker Cancer Center | |
Red Bank, New Jersey, United States, 07701 | |
South Jersey Regional Cancer Center | |
Millville, New Jersey, United States, 08332 | |
Kimball Medical Center | |
Lakewood, New Jersey, United States, 08701 | |
United States, Pennsylvania | |
Bon Secours-Holy Family Health System | |
Altoona, Pennsylvania, United States, 16602 | |
Conemaugh Memorial Hospital | |
Johnstown, Pennsylvania, United States, 15905 | |
Southern Chester County Medical Center | |
West Grove, Pennsylvania, United States, 19390 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
North Penn Hospital | |
Lansdale, Pennsylvania, United States, 19446-1200 | |
Paoli Memorial Hospital | |
Paoli, Pennsylvania, United States, 19301-1792 | |
Pinnacle Health Hospitals | |
Harrisburg, Pennsylvania, United States, 17105-8700 | |
Pottstown Memorial Regional Cancer Center | |
Pottstown, Pennsylvania, United States, 19464 | |
Reading Hospital and Medical Center | |
Reading, Pennsylvania, United States, 19612-6052 | |
Saint Mary Regional Center | |
Langhorne, Pennsylvania, United States, 19047 | |
Delaware County Memorial Hospital | |
Drexel Hill, Pennsylvania, United States, 19026 |
Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000068772, FCCC-95043, NCI-G01-1985 |
Study First Received: | July 11, 2001 |
Last Updated: | October 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00021359 |
Health Authority: | United States: Federal Government |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Isotretinoin Tretinoin Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Hormones |
Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Dermatologic Agents Central Nervous System Agents |