Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT01014767
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Standard Arm, Cycle 2: 350 mg/m2 IV over 2 hours on day 2 and 3 All Arms, Cycles 4 \& 6: 350 mg/m2 IV over 2 hours on day 2 and 3
  • Cisplatin — DRUG
    Cycles 1 \& 2: 70 mg/m²/d IV over 6 hours on day 4
  • Cyclophosphamide — DRUG
    Standard Arm, Cycle 1: 1 g/m\^2 IV over 1 hour on day 2 and 3 All Arms, Cycles 3 \& 5: 1 g/m\^2 IV over 1 hour on day 2 and 3
  • Dactinomycin — DRUG
    Cycles 1 \& 2: 45 µg/kg/day (max. 2 mg), IV on day 1
  • Doxorubicin — DRUG
    Cycles 1 \& 2: 25 mg/m²/day IV over 12 hrs on days 1-3
  • Etoposide — DRUG
    Standard Arm (1), Cycles 1 \& 2: 100 mg/m2 IV over 1 hour on days 1-5 All Arms, Cycles 4-6: 100 mg/m2 IV over 1 hour on days 1-5
  • Irinotecan — DRUG
    Temozolomide Irinotecan arm (4), Cycles 1 \& 2: 50 mg/m2/day x 5 days as 1 hour IV infusions
  • Leucovorin — DRUG
    Given with Methotrexate as leucovorin rescue at hour 42 given three times on days 1, 15 and 29.
  • Methotrexate — DRUG
    5g/m2 IV over 24 hours with leucovorin rescue at hour 42 given three times on days 1, 15 and 29.
  • Temozolomide — DRUG
    150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day IV x 5 days as one hour infusions.
  • Vincristine — DRUG
    Standard Arm (1), Cycles 1 \& 2 : 1.5 mg/m\^2 IV over 15 minutes on day 5 Doxorubicin/cisplatin arm (2), Cycles 1 \& 2: 1.5 mg/m\^2/day (max. 2 mg), i.v. on days 8, 15 For all Groups, Cycles 3 - 6: 1.5 mg/m2 IV over 15 minutes on day 5

Study Details

This is a "tissue banking and data review" research study that also has a "clinical" research part: * The goal of the tissue banking part of this study is to store tissue in a research tissue bank by the International Society for Pediatric Oncology (SIOP) at an international reference center for choroid plexus tumors. The tissue will be used in future research related to cancer. * The goal of the data review part of this study is to collect information from the medical records of patients with choroid plexus tumors, and to store the information in SIOP databases for use in future research related to cancer. * The goal of this clinical research study is to compare 4 chemotherapy treatments for choroid plexus tumors. The safety and level of effectiveness of these study treatments will be compared and studied. The study drugs include different combinations of etoposide, carboplatin, vincristine, cyclophosphamide, methotrexate, doxorubicin, cisplatin, dactinomycin, temozolomide, and irinotecan.

Key Dates

Start date
Nov 30, 2009
Status verified
Aug 2019
Primary completion
Oct 31, 2013
Completion
Jan 31, 2014

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Standard Arm (1)
    Alternating chemotherapy cycles with etoposide 100 mg/m2 over 1 hour on days 1-5, carboplatin 350 mg/m2 over 2 hours on day 2 and 3, vincristine 1.5 mg/m2 on day 5 alternating with: etoposide 100 mg/m2 over 1 hour on days 1-5, cyclophosphamide 1 g/m2 over 1 hour on day 2 and 3, vincristine 1.5 mg/m2 on day 5. Six blocks are given in 4 week intervals (day1 to day1). Radiation is given between the second and the third cycle only to a small subgroup of patients defined by age histology staging and response to the first to cycles of chemotherapy.
  • Experimental: Doxorubicin/cisplatin arm (2)
    Doxorubicin 25 mg/m²/day over 12 hrs on days 1-3, Dactinomycin 45 µg/kg/day (max. 2 mg), i.v. on day 1, and Cisplatin 70 mg/m²/d over 6 hrs on day 4, and Vincristine 1.5 mg/m²/day (max. 2 mg), i.v. on days 8, 15. An identical second cycle is started on day 28 if the side effects allow it. The further treatment is identical to the standard arm with four more cycles of chemotherapy following radiation in some of the patients in all treatment arms.
  • Experimental: Methotrexate Arm (3)
    Methotrexate 5g/m\^2 over 24 hours with leucovorin rescue at hour 42 given three times on days 1 15 and 29. The further treatment is identical in all four treatment arms.
  • Experimental: Temozolomide Irinotecan arm (4)
    Temozolomide is given at 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day x 5 days as one hour infusions. Two of these cycles are followed by the common radiation - four cycle chemotherapy protocol.

Primary Outcome Measure

Time to Disease Progression [ Time Frame: Till disease progression or death (up to 6 cycles of 28-day treatment) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111-
Children's Cancer Hospital at UT MD Anderson Cancer CenterHoustonTexas77030-

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