Pilot Study of MGd + High-dose MTX-Based Chemoimmunotherapy + RT for Newly Dx PCNSL

EARLY_PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 30, 2008

Conditions
Brain and Central Nervous System TumorsLymphomaNeurotoxicity
Interventions
BIOLOGICAL

Rituximab

Infusion will be given at week 2, week 4, week 6 and week 8. Infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.

DRUG

Cytarabine

Administered by IV over 3 hours at a dose of 3 g/m2/day for 2 days given at week 17 and week 21.

DRUG

Methotrexate

Administered by IV at dose of 3.5 grams/m2 on day 1 of week 1, week 3, week 5, week 7 and week 9; if CSF was positive it will also be given intrathecally on day 8 of week 1, week 3, week 5, week 7 and week 9.

DRUG

Motexafin gadolinium

"* Administered to the first five patients enrolled on trial, MGd will be given at 5 mg/kg q day x2 doses (completed on 2 consecutive days 1 to 2 weeks prior to day of cycle 1) to be followed by a non-infused MRI (without contrast) 1-5 hours after 2nd MGd dose (to evaluate for MGd tumor selective uptake).~* For induction chemotherapy, MGd 10 mg/kg will be given intravenously on day 8 of each cycle. MGd will be given immediately after Rituxan.~* During radiation therapy, MGd will be administered at 5 mg/kg 2-5 hours prior to WBRT, daily for the first 10 days (fractions) and then every other day of radiation thereafter."

DRUG

Procarbazine hydrochloride

Taken orally, 100 mg/m2 days 1-7 of the 1st, 3rd, and 5th cycles of induction therapy.

DRUG

Vincristine sulfate

Administered by IV at a dose of 1.4mg per meter squared on weeks 1, 3, 5, 7 and 9.

RADIATION

Radiation therapy

Given at weeks 11 through 16.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Northwestern University

OTHER

NCT00734773 - Pilot Study of MGd + High-dose MTX-Based Chemoimmunotherapy + RT for Newly Dx PCNSL | Biotech Hunter | Biotech Hunter