Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01511562

Purpose

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: carmustine Drug: cytarabine Drug: etoposide Drug: thiotepa Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Thiotepa Cytarabine Carmustine Etoposide Etoposide phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Two-year PFS [ Designated as safety issue: No ]

Secondary Outcome Measures:

EFS and OS estimated for each arm by Kaplan-Meier method, and compared between the two arms using the log-rank test [ Designated as safety issue: No ]
Toxicity rate compared between the arms using Fisher's exact method [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	January 2012
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Beginning 2-4 weeks after stem cell mobilization, patients receive high-dose therapy comprising carmustine IV over 2 hours on day -6 and thiotepa IV over 2 hours on days -5 to -4. Beginning on day 4, patients also receive filgrastim subcutaneously (SC) until absolute neutrophil count recovers. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.	Drug: carmustine Given IV Drug: thiotepa Given IV Procedure: autologous hematopoietic stem cell transplantation Undergo autologous HSCT Procedure: peripheral blood stem cell transplantation Undergo autologous HSCT
Experimental: Arm II Beginning at least 8 weeks after completion of induction therapy, patients receive cytarabine IV over 2 hours on days 1-4, and etoposide IV continuously over 96 hours on days 1-4. Beginning on day 14, patients also receive filgrastim SC until absolute neutrophil count recovers.	Drug: cytarabine Given IV Drug: etoposide Given IV

Arms

Assigned Interventions

Experimental: Arm I

Beginning 2-4 weeks after stem cell mobilization, patients receive high-dose therapy comprising carmustine IV over 2 hours on day -6 and thiotepa IV over 2 hours on days -5 to -4. Beginning on day 4, patients also receive filgrastim subcutaneously (SC) until absolute neutrophil count recovers. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.

Drug: carmustine

Given IV

Drug: thiotepa

Given IV

Procedure: autologous hematopoietic stem cell transplantation

Undergo autologous HSCT

Procedure: peripheral blood stem cell transplantation

Undergo autologous HSCT

Experimental: Arm II

Beginning at least 8 weeks after completion of induction therapy, patients receive cytarabine IV over 2 hours on days 1-4, and etoposide IV continuously over 96 hours on days 1-4. Beginning on day 14, patients also receive filgrastim SC until absolute neutrophil count recovers.

Drug: cytarabine

Given IV

Drug: etoposide

Given IV

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of primary central nervous system (CNS) diffuse large B-cell lymphoma confirmed by one of the following:
- Brain biopsy or resection
- Cerebrospinal fluid
- Vitreous fluid
No evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS
No isolated ocular lymphoma or isolated leptomeningeal lymphoma
At least one measurable, contrast-enhancing brain lesion (≥ 1 cm in length)

PATIENT CHARACTERISTICS:

Karnofsky performance status ≥ 30% (≥ 50% for patients ages 60-70 years)
Adequate cardiac function (left ventricular ejection fraction [LVEF] ≥ 50%) and pulmonary function (corrected diffusion capacity of carbon monoxide [DLCO] ≥ 60% predicted)
Pregnant or nursing patients may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
Negative human immunodeficiency virus (HIV) serology
Negative hepatitis B virus (HBV) and hepatitis C virus (HCV) serology (unless HBV antibody [HBsAb]-positive patient has recently received HBV vaccine, in this case HBcAb should be negative)
Absolute neutrophil count (ANC) ≥ 1500/mcL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (ULN)
Bilirubin ≤ 3 mg/dL
Creatinine clearance ≥ 50 mL/min
Platelet count ≥ 100,000/mcL

PRIOR CONCURRENT THERAPY:

No history of organ transplantation or ongoing immunosuppressant therapy
No concurrent palliative radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511562

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Tracy Batchelor, MD, MPH

Massachusetts General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT01511562 History of Changes
Other Study ID Numbers:	CDR0000721927, CALGB-51101
Study First Received:	January 13, 2012
Last Updated:	January 13, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

primary central nervous system non-Hodgkin lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma

stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Carmustine
Thiotepa
Etoposide phosphate
Cytarabine
Etoposide
Antineoplastic Agents, Alkylating

Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 20, 2012