Interleukin-12 in Treating Patients With Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

Phase II of Interleukin-12 for Plateau Phase Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003149
• Other study ID #: CDR0000065934
• Secondary ID: E-1A96
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 20, 2013
• Start date: December 1997
• Est. completion date: September 2006

Study information

• Verified date: March 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's blood cells to kill multiple myeloma cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-12 given at different times in treating patients with multiple myeloma.

Description:

OBJECTIVES: I. Evaluate the antitumor activity of interleukin-12 (IL-12) in patients with plateau phase multiple myeloma. II. Evaluate the toxic effects of IL-12 in these patients. III. Evaluate the effectiveness of IL-12 in augmenting T helper subsets in these patients.

OUTLINE: This is a randomized study. Patients are stratified by prior bone marrow transplantation (yes vs no) and by prior pneumococcal vaccine (Pnu-Immune-23) (yes vs no or unknown). Patients are randomized to one of two treatment arms: Arm I: Patients receive Haemophilus influenzae b vaccine (Hib TITER) and Pnu-Immune-23 on day 1 during week 1. Patients who have received Pnu-Immune-23 within the past 3 years receive Hib TITER but no Pnu-Immune-23. Patients receive low dose interleukin-12 (IL-12) subcutaneously (SQ) twice a week during weeks 1 and 2. Beginning on day 1 of week 3, patients receive high dose IL-12 SQ twice a week for an additional 12 weeks. Arm II: Patients receive Hib TITER and Pnu-Immune-23 as in arm I. Patients undergo observation during weeks 1-4, then receive low dose IL-12 SQ twice a week during weeks 5 and 6. Beginning on day 1 of week 7, patients receive high dose IL-12 SQ twice a week for an additional 12 weeks. Both arms: Patients without disease progression may continue to receive high dose IL-12 for an additional 14 weeks. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically proven plateau phase multiple myeloma at original diagnosis: Bone marrow plasmacytosis with greater than 10% plasma cells, sheets of plasma cells, or biopsy proven plasmacytoma Must be in stable plateau phase requiring objective response, no evidence of continuing improvement by any criteria, and less than 20% variation in M protein at least 4 weeks prior to study Must have at least one of the following at original diagnosis: M protein in serum or urine X-ray evidence of osteolytic lesion Measurable or evaluable M protein Serum M protein greater than 1.0 g/dL Urine M protein greater than 200 mg/24 hours M protein less than these values will be considered evaluable (serum less than 1 g/dL or urine less than 200 mg/24 hours) Nonsecretory patients are ineligible

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy:

Not specified Hematopoietic: WBC at least 2,500/mm3 Absolute neutrophil count at least 1,250/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT less than 1.5 times ULN Renal: Creatinine clearance at least 50 mL/min Cardiovascular: No New York Heart Association class III or IV congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled peptic ulcer disease No inflammatory bowel disease No history of significant autoimmune disease (rheumatoid arthritis or systemic lupus erythematosus)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 60 days since prior biologic response modifiers At least 60 days since prior bone marrow transplantation Chemotherapy: At least 60 days since prior chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Biological:
• recombinant interleukin-12

Locations

Country	Name	City	State
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Hunterdon Regional Cancer Center	Flemington	New Jersey
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	University of Rochester Cancer Center	Rochester	New York
United States	Overlook Hospital	Summit	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lacy MQ, Blood E, Kay N, et al.: Interleukin-12 treatment for plateau phase multiple myeloma: an Eastern Cooperative Oncology Group (ECOG) phase II trial (E1A96). [Abstract] Blood 100 (11 pt 1): A-1549, 2002.

Lacy MQ, Jacobus S, Blood EA, Kay NE, Rajkumar SV, Greipp PR. Phase II study of interleukin-12 for treatment of plateau phase multiple myeloma (E1A96): a trial of the Eastern Cooperative Oncology Group. Leuk Res. 2009 Nov;33(11):1485-9. doi: 10.1016/j.leu — View Citation