SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
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Purpose
This phase II trial is studying how well giving SGN-30 together with combination chemotherapy works in treating patients with newly diagnosed anaplastic large cell lymphoma. Monoclonal antibodies, such as SGN-30, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving SGN-30 together with combination chemotherapy may kill more cancer cells
| Condition | Intervention | Phase |
|---|---|---|
|
Anaplastic Large Cell Lymphoma |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: vincristine sulfate Drug: prednisone |
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 Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma |
- Objective response rate (ORR) defined as the proportion of patients experiencing a complete or partial response to a regimen of SGN-3- + CHOP [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]An ORR of 80% or higher would be evidence of sufficient activity to warrant further study of this treatment combination. Descriptive statistics will be used to report results.
| Estimated Enrollment: | 54 |
| Study Start Date: | August 2006 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Monoclonal antibody SGN-30 monotherapy: Patients receive monoclonal antibody SGN-30 IV over 2 hours once weekly for 3 weeks. Monoclonal antibody SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, patients receive monoclonal antibody SGN-30 IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. |
Drug: cyclophosphamide
Given IV
Other Names:
Drug: doxorubicin hydrochloride
Given IV
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: prednisone
Given orally
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the efficacy of monoclonal antibody SGN-30 in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) in patients with newly diagnosed anaplastic large cell lymphoma (ALCL).
II. Determine the safety of combining monoclonal antibody SGN-30 with CHOP chemotherapy.
SECONDARY OBJECTIVES:
I. Determine whether monoclonal antibody SGN-30 can induce apoptosis of ALCL cells in vivo.
II. Determine the response duration in patients treated with this regimen. III. Correlate response with pretreatment serum CD30 levels. IV. Determine response to single-agent monoclonal antibody SGN-30.
OUTLINE: This is a multicenter study. Patients are stratified according to anaplastic large cell kinase (ALK) status (positive vs negative).
Monoclonal antibody SGN-30 monotherapy: Patients receive monoclonal antibody SGN-30 IV over 2 hours once weekly for 3 weeks.
Monoclonal antibody SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, patients receive monoclonal antibody SGN-30 IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed systemic anaplastic large cell lymphoma (ALCL)
- Tissue available for the determination of anaplastic large cell kinase (ALK) status [t(2;5), ALK-NPM translocation] prior to study entry
- Prior steroids or topical treatments are allowed. Patients who are on chronic steroid therapy may receive concomitant steroids provided they have been on a stable dosage for at least 3 months prior to enrollment
- Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension (longest diameter to be recorded) as >= 20 mm by conventional techniques or as >= 10 mm by spiral CT scan
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- WBC >= 3,000/mm³
- Absolute neutrophil count >= 1,500/mm³
- Platelet count >= 100,000/mm³ (unless due to lymphoma [i.e., splenomegaly and/or bone marrow involvement])
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- AST or ALT =< 2.5 times ULN
- Creatinine =< 1.5 times ULN (unless due to lymphoma) OR creatinine clearance >=60 mL/min
- LVEF >= 50%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Exclusion Criteria:
- No rapidly progressing disease or bulky disease, defined as a mass of > 7 cm in largest diameter
- No primary cutaneous ALCL
- No known brain metastases
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to monoclonal antibody SGN-30
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would preclude study compliance
- No prior or other concurrent malignancy with < 90% probability of survival at 5 years
- No other concurrent anticancer agents or therapies
- No prior chemotherapy for ALCL
- No other concurrent investigational agents
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00365274 History of Changes |
| Other Study ID Numbers: | NCI-2009-00162, 2005-0627, N01CM62202, N01CM17003 |
| Study First Received: | August 16, 2006 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell Cyclophosphamide Doxorubicin Prednisone Vincristine Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 19, 2013