Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors
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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 |
- 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 |
| Primary Completion Date: | October 2013 (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:
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:
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:
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:
Drug: Dactinomycin
Cycles 1 & 2: 45 µg/kg/day (max. 2 mg), IV on day 1
Other Names:
Drug: Doxorubicin
Cycles 1 & 2: 25 mg/m²/day IV over 12 hrs on days 1-3
Other Names:
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:
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:
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:
Drug: Leucovorin
Given with Methotrexate as leucovorin rescue at hour 42 given three times on days 1, 15 and 29.
Other Names:
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:
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:
Drug: Irinotecan
Temozolomide Irinotecan arm (4), Cycles 1 & 2: 50 mg/m2/day x 5 days as 1 hour IV infusions Other Names:
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| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Slides have been sent to the pathology reference center (by declaration of the sending center).
- Informed consent signed
- The first registration on the study was completed or was sent with the same mail or fax or electronic registration.
- The reference center has confirmed the receipt of slides sent.
- The postoperative imaging has been done and the result is available.
- 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.
- The agreement of patient or legal guardian has been documented according to the local guidelines.
- For females in reproductive age: pregnancy test negative (both urine or blood test acceptable)
- Females in reproductive age, patients must agree to use a medically accepted method of contraception while receiving protocol-specified medication.
Exclusion Criteria:
- Previous chemotherapy
- Previous radiation therapy of the central nervous system
- White blood cell count < 2000/ uL
- Platelet count < 85 000 / uL
- 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
- Hearing loss more than 30 dB at 3000 Hz or more than 40 dB at 4000 Hz.
- Echocardiography indicates myocardial dysfunction or weakness
- Patients who are involuntarily hospitalized because of mental illness
- Pregnancy
- ALT or AST elevated higher than three times the upper normal level.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01014767
| 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 | |
| Principal Investigator: | Johannes Wolff, MD | Pending |
More Information
| 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: | July 21, 2016 |
| 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 Liposomal doxorubicin Irinotecan Etoposide phosphate Temozolomide Cisplatin |
Cyclophosphamide Carboplatin Methotrexate Doxorubicin Camptothecin Etoposide Dacarbazine Vincristine Dactinomycin Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on September 23, 2016