A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma
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.
Interventional
Primary Purpose: Treatment
Russell J. Schilder, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000068772
NCT00021359
August 1999
October 2005
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Community Medical Center | Toms River, New Jersey 08755 |
St. Francis Medical Center | Trenton, New Jersey 08629 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
South Jersey Regional Cancer Center | Millville, New Jersey 08332 |
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly, New Jersey 08060 |
Hunterdon Regional Cancer Center | Flemington, New Jersey 08822 |
Kimball Medical Center | Lakewood, New Jersey 08701 |
Riverview Medical Center - Booker Cancer Center | Red Bank, New Jersey 07701 |
Saint Mary Regional Center | Langhorne, Pennsylvania 19047 |
North Penn Hospital | Lansdale, Pennsylvania 19446-1200 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Pinnacle Health Hospitals | Harrisburg, Pennsylvania 17105-8700 |
Conemaugh Memorial Hospital | Johnstown, Pennsylvania 15905 |
Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania 19464 |
Bon Secours-Holy Family Health System | Altoona, Pennsylvania 16602 |
Southern Chester County Medical Center | West Grove, Pennsylvania 19390 |