Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

NCT01014767 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: CPT-SIOP-2009
• Study Type: interventional
• Target: 27
• Locations: 4 countries
• Sites: 5

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.

Conditions

Brain Cancer; Choroid Plexus Tumors

Keywords

Choroid Plexus Tumors; Brain Tumor; Chemotherapy; Etoposide; Carboplatin; Vincristine; Cyclophosphamide; Methotrexate; Doxorubicin; Cisplatin; Dactinomycin; temozolomide; irinotecan; Pediatrics

Outcome Measures

Primary Outcomes (2)

• Time to Disease Progression

  PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available

  Till disease progression or death (up to 6 cycles of 28-day treatment)

• Toxicity During First 4 Months of Therapy

  PI is no longer with the institution. All efforts have been exhausted to locate this data, but this data is no longer available

  4 Months

Study Arms (4)

Standard Arm (1)

EXPERIMENTAL

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; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Vincristine

Doxorubicin/cisplatin arm (2)

EXPERIMENTAL

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; Drug: Cisplatin; Drug: Cyclophosphamide; Drug: Dactinomycin; Drug: Doxorubicin; Drug: Etoposide; Drug: Vincristine

Methotrexate Arm (3)

EXPERIMENTAL

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; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Leucovorin; Drug: Methotrexate; Drug: Vincristine

Temozolomide Irinotecan arm (4)

EXPERIMENTAL

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; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Irinotecan; Drug: Temozolomide; Drug: Vincristine

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

Also known as: Paraplatin

Doxorubicin/cisplatin arm (2); Methotrexate Arm (3); Standard Arm (1); Temozolomide Irinotecan arm (4)

Cisplatin DRUG

Cycles 1 \& 2: 70 mg/m²/d IV over 6 hours on day 4

Also known as: Platinol-AQ, Platinol, CDDP

Doxorubicin/cisplatin arm (2)

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

Also known as: Cytoxan, Neosar

Doxorubicin/cisplatin arm (2); Methotrexate Arm (3); Standard Arm (1); Temozolomide Irinotecan arm (4)

Dactinomycin DRUG

Cycles 1 \& 2: 45 µg/kg/day (max. 2 mg), IV on day 1

Also known as: Cosmegen, Actinomycin D

Doxorubicin/cisplatin arm (2)

Doxorubicin DRUG

Cycles 1 \& 2: 25 mg/m²/day IV over 12 hrs on days 1-3

Also known as: Adriamycin, Rubex

Doxorubicin/cisplatin arm (2)

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

Also known as: VePsid, VP16

Doxorubicin/cisplatin arm (2); Methotrexate Arm (3); Standard Arm (1); Temozolomide Irinotecan arm (4)

Irinotecan DRUG

Temozolomide Irinotecan arm (4), Cycles 1 \& 2: 50 mg/m2/day x 5 days as 1 hour IV infusions

Also known as: CPT-11, Camptosar

Temozolomide Irinotecan arm (4)

Leucovorin DRUG

Given with Methotrexate as leucovorin rescue at hour 42 given three times on days 1, 15 and 29.

Also known as: Citrovorum, Wellcovin

Methotrexate Arm (3)

Methotrexate DRUG

5g/m2 IV over 24 hours with leucovorin rescue at hour 42 given three times on days 1, 15 and 29.

Methotrexate Arm (3)

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.

Also known as: Temodar

Temozolomide Irinotecan arm (4)

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

Doxorubicin/cisplatin arm (2); Methotrexate Arm (3); Standard Arm (1); Temozolomide Irinotecan arm (4)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (5)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Children's Cancer Hospital at UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

St. Hedwig Children's Hospital, University of Regensburg (International Study Center)

Regensburg, Germany

Location

Semmelweis University

Budapest, Hungary

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Related Links

• Neuro-Oncology 17:v186-v187, 2015.

MeSH Terms

Conditions

Brain Neoplasms; Choroid Plexus Neoplasms

Interventions

Carboplatin; Cisplatin; Cyclophosphamide; Dactinomycin; Doxorubicin; Etoposide; Irinotecan; Leucovorin; Methotrexate; Temozolomide; Vincristine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Ventricle Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Indolizidines; Indolizines

Limitations and Caveats

Data unavailable at sponsoring institution due to departure of PI. Data were stored and analyzed centrally at another site.

Results Point of Contact

• Title: Research Administration
• Organization: Tufts Medical Center

mcoughlin@tuftsmedicalcenter.org

617-636-1142

Study Officials

• Johannes Wolff, MD

  Pending

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 17, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-08

Locations

DE (1); HU (1); NZ (1); US (2)