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Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma

Information source: Fundació Sant Joan de Déu
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroblastoma; Neoplasm, Residual; Effects of Immunotherapy

Intervention: Dinutuximab. Immunotherapy (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Fundació Sant Joan de Déu

Official(s) and/or principal investigator(s):
Jaume Mora, MD, Principal Investigator, Affiliation: Hospital Sant Joan de Deu, Barcelona

Overall contact:
Jaume Mora, MD, Phone: +34 93 434 44 12, Email: investigacion@mfar.net

Summary

The purpose of this study is to evaluate safety of the triple COG schema with the monoclonal antibody Dinutuximab + cytokines (GM-CSF and IL2) and isotretinoin (13-cis-retinoic acid, or RA) in patients with high-risk neuroblastoma.

Clinical Details

Official title: Phase II Single Arm Study to Assess Dinutuximab (Ch 14.18) Combined With the Cytokines Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) and IL-2 in Patients With High-risk Neuroblastoma Not Eligible to Other Immunotherapy Trials

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants with Serious and Non-Serious Adverse Events

Secondary outcome: Relapse-free survival

Detailed description: Assess toxicity and safety of subcutaneous GM-CSF and iv IL-2 in enhancing Dinutuximab-mediated ablation of Bone Marrow (BM) disease in patients with high-risk neuroblastoma who have achieved a Complete Response or Very Good Partial Response of the macroscopic disease in the investigators institution. Assess response of minimal residual disease (MRD) of the anti-GD2 monoclonal antibody Dinutuximab combined with granulocyte-macrophage colony stimulating factor (GM-CSF) and IL-2 in patients with high-risk neuroblastoma (NB). More precisely, to apply real-time quantitative RT-PCR to test the hypothesis that minimal residual disease content of BM after the first treatments with dinutuximab/GM-CSF has significant prognostic impact on relapse-free survival.

Eligibility

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of neuroblastoma as defined by international criteria by histopathology or

bone marrow metastases. Patients age must be less than 18 years.

- Neuroblastoma, as defined by risk-related treatment guidelines and the International

Neuroblastoma Staging System, stage 4 with (any age) or without (>18 months) MYCN-amplification, or MYCN-amplified neuroblastoma other than stage 1, or high-risk neuroblastoma defined based on the 3-gene molecular profile developed at our institution (Garcia I, et al. CCR 2012).

- Group 1 patients have neuroblastoma (as defined above) resistant to standard

therapy, as evidenced by incomplete response in bone marrow, but no MIBG-avid soft tissue or bone tumor and no progressive disease.

- Group 2 patients have no evidence of measurable disease

- Pre-enrollment tumor survey: Prior to enrollment a determination of residual disease

must be performed (Tumor imaging studies including CT or MRI, MIBG scan, bone marrow aspiration & biopsy, and blood and bone marrow samples). This disease assessment is required for eligibility.

- Patients must have a Lansky or Karnofsky Performance Scale score of > 50% and

patients must have a life expectancy of > 2 months.

- Patients must have adequate organ functions at the time of registration:

- Hematological: Total absolute phagocyte count (APC = neutrophils + monocytes) is

at least 1000/microL

- Renal: Adequate Renal Function Defined As: Creatinine clearance or radioisotope

GFR > 70 mL/min/1. 73 m2 or serum creatinine based on age/gender.

- Hepatic- total bilirubin < 1. 5 x normal, and SGPT (ALT) < 5 x normal.

Veno-occlusive disease, if present, should be stable or improving.

- Cardiac- shortening fraction of > 30% by echocardiogram, or if shortening

fraction abnormal, ejection fraction of > 55% by gated radionuclide study.

- Pulmonary- FEV1 and FVC > 60% of predicted by pulmonary function test. For

children who are unable to do PFTs, no evidence of dyspnea at rest, no exercise intolerance.

- Central nervous system- Patients with seizure disorder may be enrolled if on

anticonvulsants and wellcontrolled. CNS toxicity < Grade 2.

- Females of childbearing potential must have a negative pregnancy test. Patients of

childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.

- Signed informed consent indicating awareness of the investigational nature of this

program. Exclusion Criteria:

- Existing severe major organ dysfunction, i. e., renal., cardiac, hepatic, neurologic,

pulmonary, or gastrointestinal toxicity ≥ grade 3.

- Progressive disease or MIBG-avid soft tissue/bone tumor.

- Active life-threatening infection.

- Inability to comply with protocol requirements.

- Patient is eligible for SIOP HR-NB-01 protocol (= newly diagnosed high-risk

neuroblastoma patient in a center where the SIOP protocol is open for enrollment).

Locations and Contacts

Jaume Mora, MD, Phone: +34 93 434 44 12, Email: investigacion@mfar.net

Hospital Sant Joan de Deu, Barcelona, Spain; Not yet recruiting
Additional Information

Starting date: June 2014
Last updated: June 18, 2014

Page last updated: August 23, 2015

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