Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma
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Purpose
RATIONALE: Combinations of biological substances in alefacept may be able to carry cancer-killing substances directly to cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Alefacept |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-cell Lymphoma and Peripheral T-cell NHL |
- Tolerability [ Time Frame: 9/21/2006 - 7/06/2010 ] [ Designated as safety issue: Yes ]
- Immunostimulation [ Time Frame: 9/22/2006 - 6/08/2010 ] [ Designated as safety issue: No ]
- Clinical response [ Time Frame: 1/05/2007 - 2/25/2011 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | May 2013 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: alefacept
Determine both the maximum tolerated dose level as well as the optimal immunologic dose and toxicity.
|
Drug: Alefacept
Dose escalation theme. 0.075mg/kg by IV Weekly x 8 to 0.30mg/kg IV Weekly x 8
Other Name: Amevive
|
Detailed Description:
OBJECTIVES:
Primary
- Determine the maximum tolerated dose or the optimal immunologic dose of alefacept in patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma.
Secondary
- Determine if antitumor activity of this drug exists in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
- Induction therapy: Patients receive alefacept IV over 2-5 minutes once weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or complete or partial response after induction therapy proceed to maintenance therapy.
Cohorts of 6 patients receive escalating doses of alefacept until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The optimal immunologic dose is defined as the dose that does not exceed the MTD, has the highest alefacept level, and achieves saturation of CD2 receptors.
- Maintenance therapy: Patients receive alefacept IV on day 1. Treatment repeats every 4 weeks for 10-12 courses in the absence of disease progression or unacceptable toxicity.
Patients who experience disease progression during maintenance therapy may receive reinduction therapy* comprising 4 weekly doses of alefacept. The patient then proceeds to a second maintenance phase in the absence of disease progression.
NOTE: *Only 1 reinduction allowed.
Patients undergo blood and tissue collection periodically for pharmacological studies. Blood serum is analyzed for alefacept concentration, cytokine concentration, CD16 polymorphisms, and CD2 saturation via flow cytometry.
After completion of study treatment, patients are followed every 3 months for up to 3 years and then periodically thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous T-cell lymphoma (CTCL) or peripheral T-cell non-Hodgkin's lymphoma
- Diagnostic biopsies must have been obtained within the past 6 months
Relapsed or refractory disease
Patients with CTCL must have failed ≥ 2 skin-directed therapies
- No limit on the number of prior therapies
Measurable disease, defined as at least 1 bidimensionally measurable lesion > 2 cm by CT scan, MRI, physical exam, or photograph with appended ruler
- At least 2 bidimensionally measurable target lesions required for patients with skin lesions only
- No CNS lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times ULN
- AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)
- Creatinine ≤ 2 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to provide all research blood samples as required by the protocol
- Willing to undergo repeat biopsy of either an accessible skin lesion or lymph node, if there are no circulating sezary cells, for the purpose of research studies (patients without easily accessible lesions are not required to have a repeat biopsy solely for research purposes but must be willing to provide a portion of the on-study biopsy or a previous lymphoma biopsy, if available)
- No known congenital or acquired immunodeficiency syndromes, including HIV
- No known active viral hepatitis or tuberculosis infection
- No uncontrolled infection
- No other uncontrolled serious medical condition unrelated to lymphoma (e.g., cardiac arrhythmia or diabetes)
- No other active malignancies
- No history of serious allergic reaction to citrate or glycine
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 weeks since prior cytotoxic chemotherapy
- More than 3 weeks since prior denileukin diftitox
- More than 3 weeks since prior radiotherapy (less than 3 weeks if the acute side effects of this therapy are resolved)
- More than 2 weeks since prior oral corticosteroids (unless being used to treat adrenal insufficiency)
- More than 2 weeks since prior phototherapy, including ultraviolet B and psoralen with ultraviolet A
- More than 1 week since prior biologic therapy
- No concurrent chemotherapy, other immunotherapy, or radiotherapy
- No other concurrent investigational agents
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1002 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Thomas E. Witzig, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00438802 History of Changes |
| Other Study ID Numbers: | CDR0000530071, P50CA097274, P30CA015083, LS058C, 06-002246 |
| Study First Received: | February 20, 2007 |
| Last Updated: | May 22, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mayo Clinic:
|
recurrent cutaneous T-cell non-Hodgkin lymphoma angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma adult nasal type extranodal NK/T-cell lymphoma recurrent mycosis fungoides/Sezary syndrome |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Alefacept Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013