Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma

Johns Hopkins Medicine

Status and phase: Terminated; Early Phase 1

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Treatments: Biological: recombinant interleukin-6; Biological: recombinant interferon-α

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00470093

J0620

NA_00002178 (Other Identifier)

P30CA006973 (U.S. NIH Grant/Contract)

P01CA015396 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with interleukin-6 may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.

Full description

OBJECTIVES:

• Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6.
• Determine the safety and optimal dose of this regimen in these patients.
• Determine the toxicity of this regimen in these patients.
• Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays.

OUTLINE: This is a pilot study.

Patients receive recombinant interferon alfa subcutaneously (SC) once daily. Beginning 1 month later, patients also receive recombinant interleukin-6 SC once daily. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Enrollment: 3 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of recurrent multiple myeloma
• Must have received ≥ 2 prior therapies

PATIENT CHARACTERISTICS:

• Performance status 0-3

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Interleukin-6 and Interferon-α

Experimental group

Description:

Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.

Treatment:

Biological: recombinant interleukin-6

Biological: recombinant interferon-α