Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	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

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	190 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	CPT-SIOP-2009: Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Patients With Choroid Plexus Tumors
Study Start Date :	November 2009
Actual Primary Completion Date :	October 2013

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Time to Disease Progression [ Time Frame: Till disease progression or death (up to 6 cycles of 28-day treatment) ]
2. Toxicity during first 4 months of therapy [ Time Frame: 4 Months ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT01014767 History of Changes
Other Study ID Numbers:	CPT-SIOP-2009
First Posted:	November 17, 2009
Last Update Posted:	July 25, 2016
Last Verified:	July 2016

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; Liposomal doxorubicin; Irinotecan; Temozolomide; Etoposide phosphate; Cisplatin	Cyclophosphamide; Carboplatin; Doxorubicin; Methotrexate; Camptothecin; Dacarbazine; Etoposide; Vincristine; Dactinomycin; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating