A phase II study of the combination of gemcitabine with 131I-MIBG therapy for children with neuroblastoma without other treatment options.

Phase II trial of the combination of gemcitabine and 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastoma.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24917

Enrollment

Registered

2010-06-21

Start date

2010-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuroblastoma, children, relapsed, progressive

Interventions

Patients will be treated with a combination of gemcitabine and 131I-MIBG. Gemcitabine is the IMP in this study.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological proven neuroblastoma; 2. Measurable primary and/or metastatic disease; 3. Relapsed or progressive neuroblastoma in which standard approaches to treatment have failed; 4. Evidence of sufficient MIBG uptake in bone or soft tissue; 5. 1 year to 18 years of age; 6. Lansky play score >= 70%, or ECOG performance status = 6 weeks; 8. Adequate organ function including: A. Bone marrow: leukocytes > 2.0 x 10 9/L; B. ANC 100 x 10 9/L (in case of bone marrow disease: >75 x 10 9/L); D. Hepatic: Bilirubin > 1.5x upper limit of normal (ULN); AST, ALT > 5.0x ULN; E. Renal: Serum creatinine 15 years: <110μmol/L). 9. Wash out of 3 weeks of prior chemotherapy or radiotherapy (1 week if prior chemotherapy was single agent vincristine), 6 weeks if prior chemotherapy contained nitrosoureas, 6 months since ASCT was given; 10. Able to comply with scheduled follow up and management of toxicity; 11. All patients with reproductive potential must use effective contraception. Female patients with childbearing potential must have negative pregnancy test within 7 days before study treatment; 12. Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations.

Exclusion criteria

Exclusion criteria: 1. Received treatment within the last 21 days with an investigational or conventional anti-cancer drug; 2. Concurrent administration of any other anti-tumour therapy; 3. Serious concomitant disorders that would compromise patient safety; 4. Symptomatic brain metastases; 5. Contra-indication for nuclear isolation; 6. Are pregnant or breastfeeding; 7. 131I-MIBG treatment in prior 3 months; 8. Known hypersensitivity to gemcitabine.

Design outcomes

Primary

Measure	Time frame
Determination of efficacy as measured by response rate (and time-to-event measurements).	—

Secondary

Measure	Time frame
Characterization of safety and toxicity profile.	—

Contacts

Public ContactN.K.A. Eijkelenburg, van

Meibergdreef 9, F8-207

n.k.vaneijkelenburg@amc.nl+31 (0)20 5663050

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)