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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)


Phase 2
18 Years
72 Years
Open (Enrolling)
Both
CNS Lymphoma, CNS Brain Cancer, Non-Hodgkin's Lymphoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

1-year event-free survival and acute treatment-related toxicity.

Safety Issue:

Yes

Principal Investigator

Antonio Omuro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-129

NCT ID:

NCT00596154

Start Date:

December 2004

Completion Date:

December 2013

Related Keywords:

  • CNS Lymphoma
  • CNS Brain Cancer
  • Non-Hodgkin's Lymphoma
  • Brain Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at CommackCommack, New York  11725
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920