90Y DOTA/Retinoic Acid for Neuroblastoma and Neuroendocrine Tumor (NET)

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Neuroblastoma, Neuroendocrine Tumor

In brief

This study is for patients with neuroblastoma or a neuroendocrine tumor who have not been able to have standard therapy or have failed the first-line therapy. The purpose of this study is to assess the safety and effectiveness of the combination of retinoic acid and Onalta (Y-90-DOTA-tyr3-Octreotide) in treating neuroblastoma and neuroendocrine tumors.

Key facts

Study ID

NCT01048086

Run by

University of Iowa

People needed

0

Starts

2009-06-01

Expected to finish

2013-11-01

Last updated by the study team

2016-06-21

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disease Criteria
• A pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be neuroblastoma or neuroendocrine tumor. The subject's neoplastic disease must have been (positively) imaged by OctreoScan® or 111In-DOTA-tyr3-Octreotide within 4 weeks prior to ordering study drug.
• b) Disease not amenable to standard treatment (disease present after surgery and/or Sandostatin treatment) or subject has failed existing first line therapy (surgery and chemotherapy/radiation therapy).
• c) Upon baseline disease assessment, all subjects must have at least 1 measurable, evaluable, site of disease that either has never been irradiated or has been previously irradiated and has since demonstrated progression based on COG response criteria. Children's Oncology Group response criteria include: 1) Complete response (CR) is defined as no measureable disease; 2) partial response (PR) as >50% decrease in longest X widest perpendicular diameter of target lesions with no increase in any lesions and no new lesions; 3) minor response (MR) as >25%<50% decrease in target lesions with no increase in any lesion and no new lesions; 4) stable disease as <25% increase or decrease in any target lesion and no new lesions; 5) Progressive disease (PD) as an increase >25% in any measureable lesion or the presence of any new lesion was considered progressive disease (PD). Response will be assessed based on intent to treat for all subjects who receive at least one dose of 90Y-DOTA-tyr3-Octreotide.
• Each subject must have at least one measurable somatostatin receptor positive lesion that has not had local irradiation via external beam, conformal or stereotactic radiation treatments within 4 weeks prior to study drug administration and no full craniospinal radiation within 3 months prior to study drug administration.
• Bone marrow with >/= 40% cellularity or with 1 million CD34+ stem cells/kg stored.
• Life expectancy > 2 months and < 12 months.
• Biopsy of at least one lesion or bone marrow that has been identified as progressive malignancy within four weeks prior to the first dose of Onalta® is encouraged but not required. If no biopsy can be performed for clinical reasons, available tissue from a previous biopsy will be required.
• Age 6 months-30 years.
• COG performance status /= 60% or Lansky Play Scale >/= 60%).
• Patients must have normal organ and marrow function as defined below:
• absolute neutrophil count >1000/mm3
• platelets >100,000/mm3
• total bilirubin <1.5 x nl for age and weight
• AST(SGOT) \& ALT(SGPT) <2.5 X institutional upper limit of normal for age
• creatinine <1.0 for children <5 years of age; <1.2 for children 5-10 years of age; <1.7 for >10 years AND
• GFR >80 mL/min/1.73 m2
• urinalysis with no greater than 1+ hematuria or proteinuria
• Cardiac function must be adequate
• shortening fraction of > 28% by echo
• ejection fraction > 50% by bi-plane method of echo
• The effects of 90Y-DOTA-tyr3-Octreotide on the developing human fetus are unknown. Retinoic acid is known to be harmful to the developing human fetus. For these reasons and because Class C agents are known to be teratogenic, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.
• Serum triglycerides <300 mg/dL.
• Concomitant Therapy - The subject may not receive any other approved or investigational anti-neoplastic therapies for the treatment of the refractory somatostatin-receptor positive tumor during the course of the study, excluding somatostatin analogues and bisphosphonates. However, all subjects on somatostatin analogue therapy will discontinue therapy from 12 hours prior to a) injection with OctreoScan® or 111In-DOTA-tyr3-Octreotide, and b) infusion with 90Y-DOTA-tyr3-Octreotide until 12 hours post administration. Subjects who have been on hormonal therapy (other than somatostatin analogues) for > 2 months with SD or PD may continue to receive hormonal therapy during this study. Subjects who initiate another tumor-specific therapy will be discontinued from further treatment with 90YDOTA-tyr3-Octreotide. Disease progression alone does not mandate discontinuation of a subject from treatment.

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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