Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

Sponsor

Fox Chase Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00021359

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: dexamethasone Drug: isotretinoin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 1999

Actual Primary Completion Date :

Jul 1, 2000

Actual Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunterdon Regional Cancer Center	Flemington	New Jersey	United States	08822
2	Kimball Medical Center	Lakewood	New Jersey	United States	08701
3	South Jersey Regional Cancer Center	Millville	New Jersey	United States	08332
4	Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County	Mount Holly	New Jersey	United States	08060
5	Riverview Medical Center - Booker Cancer Center	Red Bank	New Jersey	United States	07701
6	Community Medical Center	Toms River	New Jersey	United States	08755
7	St. Francis Medical Center	Trenton	New Jersey	United States	08629
8	Bon Secours-Holy Family Health System	Altoona	Pennsylvania	United States	16602
9	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania	United States	19026
10	Pinnacle Health Hospitals	Harrisburg	Pennsylvania	United States	17105-8700
11	Conemaugh Memorial Hospital	Johnstown	Pennsylvania	United States	15905
12	Saint Mary Regional Center	Langhorne	Pennsylvania	United States	19047
13	North Penn Hospital	Lansdale	Pennsylvania	United States	19446-1200
14	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
15	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
16	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania	United States	19464
17	Reading Hospital and Medical Center	Reading	Pennsylvania	United States	19612-6052
18	Southern Chester County Medical Center	West Grove	Pennsylvania	United States	19390