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Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (PCNSL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00596154
First received: January 7, 2008
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to determine the safety of this new treatment offered in this study. PCNSL can be cured in less than half of patients with standard treatment, a combination of chemotherapy and brain radiation. Also, the combination of chemotherapy and brain radiation may result in serious lasting side effects. Most patients older than age 60 develop memory problems, difficulty walking or inability to control their bladder. Some patients younger than age 60 also develop these side effects.


Condition Intervention Phase
CNS Lymphoma
CNS Brain Cancer
Non-Hodgkin's Lymphoma
 Other: Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide
 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: Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (PCNSL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • to evaluate the safety and efficacy of the use of R-MPV followed by high-dose chemotherapy using thiotepa, cyclophosphamide and busulfan with stem cell rescue in patients with newly diagnosed PCSNL. [ Time Frame: 1-year event-free survival and acute treatment-related toxicity. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to evaluate response rates with the combination of rituximab and MPV as induction chemotherapy. [ Time Frame: after 5 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: December 2004
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rituximab, methotrexate (MTX), procarbazine and vincristine (R-MPV). The peripheral blood stem cell (PBSC) harvest procedure will be performed at the discretion of the hematology attending (usually after the 1st or 2nd cycle of R-MPV)and high dose chemotherapy Busulfan, Thiotepa, and Cyclophosphamide.
 Other: Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide

The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1.

On day 2 you will be admitted to the hospital and will receive 3 other drugs:

Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2.

Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle.

Other Names:
  • During each cycle, you will receive Rituximab typically as an outpatient on day 1 and then be
  • admitted on day 2 to receive the other chemotherapy. You will be in the hospital for about 5 days and will be re-admitted to the hospital about 9 days
  • later to start the next cycle. After each cycle of chemotherapy you will take a medicine called G-CSF to protect you against
  • infection. PBPCs will be collected when determined by your doctor and may occur with cycle 1 or cycle 2.
  • You will be admitted again for the high-dose chemotherapy and will receive supportive
  • medications to help avoid complications, including antibiotics and blood transfusions. Three
  • drugs, Busulfan, Thiotepa, and Cyclophosphamide will be given to you over 8 days. After a
  • rest period of approximately 1-2 days, we will give your PBPCs (or bone marrow) back to you
  • by vein. You will be in the hospital for at least 3 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must have non-Hodgkin's lymphoma involving the brain, as demonstrated by CT or MRI and histologic confirmation by one of the following: A positive CSF cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers.

A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma. Brain biopsy.

  • Patients must be HIV-1 negative.
  • Patient must have left ventricular ejection fraction ≥ 50%.
  • Patients must have no evidence of systemic lymphoma. This must be demonstrated by a CT scan of the chest, abdomen and pelvis prior to registration.
  • Patients must have adequate bone marrow function (defined as peripheral leucocyte count >3000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg%), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min/1.73M2).
  • Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
  • Patients must be between 18 and 72 years-old.
  • Patients must sign an informed consent.

Exclusion Criteria:

  • Prior cranial irradiation
  • Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
  • Pre-existing immunodeficiency such as renal transplant recipient.
  • Prior treatment with chemotherapy for CNS lymphoma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596154

Locations
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Antonio Omuro, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00596154     History of Changes
Other Study ID Numbers: 04-129
Study First Received: January 7, 2008
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Busulfan
Cyclophosphamide
Methotrexate
Thiotepa
Rituximab
Procarbazine
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013