Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

This study has suspended participant recruitment.
(PI departure from coordinating institution)
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01014767
First received: November 13, 2009
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention Phase
Brain Cancer
Choroid Plexus Tumors
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Dactinomycin
Drug: Doxorubicin
Drug: Etoposide
Drug: Irinotecan
Drug: Leucovorin
Drug: Methotrexate
Drug: Temozolomide
Drug: Vincristine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CPT-SIOP-2009: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Patients With Choroid Plexus Tumors

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Time to Disease Progression [ Time Frame: Till disease progression or death (up to 6 cycles of 28-day treatment) ] [ Designated as safety issue: Yes ]
  • Toxicity during first 4 months of therapy [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 190
Study Start Date: November 2009
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Carboplatin

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

Other Name: Paraplatin
Drug: Cyclophosphamide

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

Other Names:
  • Cytoxan
  • Neosar
Drug: Etoposide

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

Other Names:
  • VePsid
  • VP16
Drug: Vincristine

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

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.
Drug: Carboplatin

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

Other Name: Paraplatin
Drug: Cisplatin
Cycles 1 & 2: 70 mg/m²/d IV over 6 hours on day 4
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP
Drug: Cyclophosphamide

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

Other Names:
  • Cytoxan
  • Neosar
Drug: Dactinomycin
Cycles 1 & 2: 45 µg/kg/day (max. 2 mg), IV on day 1
Other Names:
  • Cosmegen
  • Actinomycin D
Drug: Doxorubicin
Cycles 1 & 2: 25 mg/m²/day IV over 12 hrs on days 1-3
Other Names:
  • Adriamycin
  • Rubex
Drug: Etoposide

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

Other Names:
  • VePsid
  • VP16
Drug: Vincristine

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

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.
Drug: Carboplatin

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

Other Name: Paraplatin
Drug: Cyclophosphamide

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

Other Names:
  • Cytoxan
  • Neosar
Drug: Etoposide

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

Other Names:
  • VePsid
  • VP16
Drug: Leucovorin
Given with Methotrexate as leucovorin rescue at hour 42 given three times on days 1, 15 and 29.
Other Names:
  • Citrovorum
  • Wellcovin
Drug: Methotrexate
5g/m2 IV over 24 hours with leucovorin rescue at hour 42 given three times on days 1, 15 and 29.
Drug: Vincristine

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

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.
Drug: Carboplatin

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

Other Name: Paraplatin
Drug: Cyclophosphamide

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

Other Names:
  • Cytoxan
  • Neosar
Drug: Etoposide

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

Other Names:
  • VePsid
  • VP16
Drug: Irinotecan

Temozolomide Irinotecan arm (4), Cycles 1 & 2:

50 mg/m2/day x 5 days as 1 hour IV infusions

Other Names:
  • CPT-11
  • Camptosar
Drug: Temozolomide
150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day IV x 5 days as one hour infusions.
Other Name: Temodar
Drug: Vincristine

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


  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological diagnosis of a choroid plexus tumor by a local pathologist/neuropathologist. This includes choroid plexus papilloma, atypical choroid plexus papilloma, anaplastic choroid plexus papilloma, malignant choroid plexus papilloma, and choroid plexus carcinoma.
  2. Slides have been sent to the pathology reference center (by declaration of the sending center).
  3. Informed consent signed
  4. The first registration on the study was completed or was sent with the same mail or fax or electronic registration.
  5. The reference center has confirmed the receipt of slides sent.
  6. The postoperative imaging has been done and the result is available.
  7. Disease status and histology: The patient is suffering from either choroid plexus carcinoma of any stage, OR an atypical choroid plexus papilloma with tumor residual after maximal possible surgical resection, OR a primary metastatic atypical choroid plexus papilloma. OR a first recurring choroid plexus papilloma that is either not resectable or was metastatic, OR a second recurrence of any choroid plexus tumor.
  8. The agreement of patient or legal guardian has been documented according to the local guidelines.
  9. For females in reproductive age: pregnancy test negative (both urine or blood test acceptable)
  10. Females in reproductive age, patients must agree to use a medically accepted method of contraception while receiving protocol-specified medication.

Exclusion Criteria:

  1. Previous chemotherapy
  2. Previous radiation therapy of the central nervous system
  3. White blood cell count < 2000/ uL
  4. Platelet count < 85 000 / uL
  5. Inadequate kidney function with Creatinine > age adapted upper normal range AND creatinine clearance or GFR determined by nuclear medicine < 70 ml/min/1.73 m2 Body surface area
  6. Hearing loss more than 30 dB at 3000 Hz or more than 40 dB at 4000 Hz.
  7. Echocardiography indicates myocardial dysfunction or weakness
  8. Patients who are involuntarily hospitalized because of mental illness
  9. Pregnancy
  10. ALT or AST elevated higher than three times the upper normal level.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014767

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Texas
Children's Cancer Hospital at UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Germany
St. Hedwig Children's Hospital, University of Regensburg (International Study Center)
Regensburg, Germany
Hungary
Semmelweis University
Budapest, Hungary
New Zealand
Christchurch Hospital
Christchurch, New Zealand
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Johannes Wolff, MD Pending
  More Information

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01014767     History of Changes
Other Study ID Numbers: CPT-SIOP-2009
Study First Received: November 13, 2009
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Choroid Plexus Tumors
Brain Tumor
Chemotherapy
Etoposide
Carboplatin
Vincristine
Cyclophosphamide
Methotrexate
Doxorubicin
Cisplatin
Dactinomycin
temozolomide
irinotecan
Pediatrics

Additional relevant MeSH terms:
Brain Neoplasms
Choroid Plexus Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Ventricle Neoplasms
Dactinomycin
Doxorubicin
Liposomal doxorubicin
Methotrexate
Etoposide phosphate
Temozolomide
Irinotecan
Cisplatin
Cyclophosphamide
Etoposide
Vincristine
Dacarbazine
Carboplatin
Leucovorin
Levoleucovorin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on September 14, 2014