Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00021359
First received: July 11, 2001
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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
Multiple Myeloma and Plasma Cell Neoplasm
Drug: dexamethasone
Drug: isotretinoin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Enrollment: 17
Study Start Date: August 1999
Study Completion Date: October 2005
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021359

Locations
United States, New Jersey
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States, 08822
Kimball Medical Center
Lakewood, New Jersey, United States, 08701
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, United States, 07701
Community Medical Center
Toms River, New Jersey, United States, 08755
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
United States, Pennsylvania
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, United States, 16602
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, United States, 17105-8700
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, United States, 15905
Saint Mary Regional Center
Langhorne, Pennsylvania, United States, 19047
North Penn Hospital
Lansdale, Pennsylvania, United States, 19446-1200
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, United States, 19464
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Southern Chester County Medical Center
West Grove, Pennsylvania, United States, 19390
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00021359     History of Changes
Other Study ID Numbers: CDR0000068772, FCCC-95043, NCI-G01-1985
Study First Received: July 11, 2001
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Isotretinoin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on April 16, 2014