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Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

Information source: Fox Chase Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma and Plasma Cell Neoplasm

Intervention: dexamethasone (Drug); isotretinoin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Fox Chase Cancer Center

Official(s) and/or principal investigator(s):
Russell J. Schilder, MD, Study Chair, Affiliation: Fox Chase Cancer Center

Summary

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.

Clinical Details

Official title: A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hunterdon Regional Cancer Center, Flemington, New Jersey 08822, United States

Kimball Medical Center, Lakewood, New Jersey 08701, United States

South Jersey Regional Cancer Center, Millville, New Jersey 08332, United States

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly, New Jersey 08060, United States

Riverview Medical Center - Booker Cancer Center, Red Bank, New Jersey 07701, United States

Community Medical Center, Toms River, New Jersey 08755, United States

St. Francis Medical Center, Trenton, New Jersey 08629, United States

Bon Secours-Holy Family Health System, Altoona, Pennsylvania 16602, United States

Delaware County Memorial Hospital, Drexel Hill, Pennsylvania 19026, United States

Pinnacle Health Hospitals, Harrisburg, Pennsylvania 17105-8700, United States

Conemaugh Memorial Hospital, Johnstown, Pennsylvania 15905, United States

Saint Mary Regional Center, Langhorne, Pennsylvania 19047, United States

North Penn Hospital, Lansdale, Pennsylvania 19446-1200, United States

Paoli Memorial Hospital, Paoli, Pennsylvania 19301-1792, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Pottstown Memorial Regional Cancer Center, Pottstown, Pennsylvania 19464, United States

Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States

Southern Chester County Medical Center, West Grove, Pennsylvania 19390, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 1999
Last updated: July 9, 2013

Page last updated: August 23, 2015

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