Clinical trial NCT00365274: SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
Official title: A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anaplastic Large Cell Lymphoma
Keywords: non-Hodgkin's lymphoma
NHL
murine monoclonal antibody
mAb
SGN-30
CHOP
Cyclophosphamide
Doxorubicin Hydrochloride
Vincristine
Prednisone
anaplastic large cell lymphoma
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, T-Cell
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics
Antineoplastic
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-08-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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 criteria: 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
* The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
* White Blood Count (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
* Left ventricular ejection fraction (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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Michelle Fanale, MD
role: PRINCIPAL_INVESTIGATOR
References: