Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Active, not recruiting
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: 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
Community Medical Center, Toms River, New Jersey 08755, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly, New Jersey 08060, United States
Hunterdon Regional Cancer Center, Flemington, New Jersey 08822, United States
Kimball Medical Center, Lakewood, New Jersey 08701, United States
Riverview Medical Center - Booker Cancer Center, Red Bank, New Jersey 07701, United States
South Jersey Regional Cancer Center, Millville, New Jersey 08332, United States
St. Francis Medical Center, Trenton, New Jersey 08629, United States
Bon Secours-Holy Family Health System, Altoona, Pennsylvania 16602, United States
Conemaugh Memorial Hospital, Johnstown, Pennsylvania 15905, United States
Delaware County Memorial Hospital, Drexel Hill, Pennsylvania 19026, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States
North Penn Hospital, Lansdale, Pennsylvania 19446-1200, United States
Paoli Memorial Hospital, Paoli, Pennsylvania 19301-1792, United States
Pinnacle Health Hospitals, Harrisburg, Pennsylvania 17105-8700, United States
Pottstown Memorial Regional Cancer Center, Pottstown, Pennsylvania 19464, United States
Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States
Saint Mary Regional Center, Langhorne, Pennsylvania 19047, 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: May 23, 2008
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