67Cu-SARTATE for Neuroblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MD Anderson Cancer Center, Houston, TX
Neuroblastoma+2 More
67Cu-SARTATE - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a radioactive substance may help treat neuroblastoma.

See full description

Eligible Conditions

  • Neuroblastoma
  • Relapsed Neuroblastoma
  • Refractory Neuroblastoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether 67Cu-SARTATE will improve 9 primary outcomes in patients with Neuroblastoma. Measurement will happen over the course of 6 weeks.

Week 8
Best response
Objective response and best response
6 weeks
Maximum Tolerated Dose (MTD) of 67Cu-SARTATE
Maximum Tolerated Dose of 67Cu-SARTATE
Up to 12 months
Overall response rate
Safety and tolerability of Cu-64 SARTATE using CTCAE version 4.03
Safety and tolerability of Cu-67 SARTATE using CTCAE version 4.03
Up to 36 months
Safety and tolerability of Cu-64 SARTATE using CTCAE
Safety and tolerability of Cu-67 SARTATE using Common Terminology Criteria for Adverse Events (CTCAE)

Trial Safety

Trial Design

1 Treatment Group

67Cu-SARTATE
1 of 1
Experimental Treatment

This trial requires 34 total participants across 1 different treatment group

This trial involves a single treatment. 67Cu-SARTATE is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

67Cu-SARTATE64Cu-SARTATE - patients will receive a bolus injection of 64Cu-SARTATE during screening, and following each 67Cu-SARTATE Therapy Cycle at a rate of 2.0 MBq/kg. 67Cu-SARTATE - In the dose escalation phase, patients will receive a single administration of 67Cu-SARTATE as an IV infusion (dose will be determined based on cohort allocation). In the expansion phase, patients will receive at least 2 administrations of 67Cu-SARTATE a the MTD level as a slow IV infusion. Participants in either phase of the study that demonstrate therapeutic benefit following treatment with 67Cu-SARTATE at any dose may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copper
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 36 months for reporting.

Closest Location

MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Neuroblastoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participant is able and willing to provide informed consent (≥18 years), or informed consent is obtained by the parent or legal guardian for minor participants, with the minor providing age appropriate assent, according to local law and regulations;
Life expectancy ≥ 12 weeks;
Known high-risk neuroblastoma OR previously intermediate-risk neuroblastoma that has relapsed or progressed to high-risk, with failure to achieve complete response with standard therapy (defined as at least 4 cycles of aggressive multi-drug induction chemotherapy with or without radiation and surgery, or according to a standard high-risk treatment/neuroblastoma protocol), OR who are medically ineligible to receive standard treatment OR who are intolerant to standard treatment;
Adequate recovery from acute toxic effects of any prior therapy, as deemed by the Investigator or treating Sub-Investigator;
Adequate liver function as defined by the following laboratory values obtained within 28 days prior to administration of 64Cu-SARTATE: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN);
Adequate renal function;
Adequate laboratory parameters: Absolute neutrophil count > 1.0 x 10 9/L; Platelet count > 50 x 10 9/L; Total bilirubin <1.5 x ULN;
Karnofsky or Lansky performance status ≥50;
All participants must have a hematopoietic stem cell product available (minimum CD34+ cell dose is ≥2 x 10 6 cells/kg);
Sexually active participants of reproductive potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus. Abstinence is considered acceptable;

Patient Q&A Section

What causes neuroblastoma?

"The data support a complex genetic background for neuroblastoma. In the majority of the children with neuroblastoma, no family history for neuroblastoma was observed. Results from a recent clinical trial suggest that genetic susceptibility to neuroblastoma may be inherited in an autosomal dominant fashion. This may apply also to some children with pheochromocytoma/parathyroid tumor, which may have similar inheritance characteristics." - Anonymous Online Contributor

Unverified Answer

How many people get neuroblastoma a year in the United States?

"In the US, neuroblastoma is diagnosed at its more aggressive stages in whites and blacks. Most children with neuroblastoma do not live past two years, but those with poor histological features live longer. The incidence of neuroblastoma varies substantially by country, and the incidence in the United States is similar to or higher than in other industrialized countries." - Anonymous Online Contributor

Unverified Answer

What is neuroblastoma?

"This common tumour type affects infants and children most often (up to 60 per cent of patients) and can spread in very rare cases to the brain. Although, as with many childhood cancers, treatment is usually only available in large, well equipped medical centres.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for neuroblastoma?

"Stem cell transplantation is very effective for treating NB and is an option for children and adults. The most usual risks of this procedure are related to infections, especially encephalitis." - Anonymous Online Contributor

Unverified Answer

What are the signs of neuroblastoma?

"The signs of neuroblastoma are related to the location of the tumor mass. Symptoms are related to the location and extent of the tumor mass, and include: abdominal discomfort or pain, nausea, vomiting, and loss of hearing." - Anonymous Online Contributor

Unverified Answer

Can neuroblastoma be cured?

"There is as yet no cure for neuroblastoma. This is due to the fact that the tumors can develop resistance to some of the treatments." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for neuroblastoma?

"Only 1 in 3 children undergoing neuroblastoma therapy currently enroll in a clinical trial. Many of these children will not benefit from treatment. Children with symptomatic disease should be considered for clinical trials. Children with minimal disease may be appropriate candidates. Children with stage 2-3 disease should be offered treatment in a clinical trial even if their disease is minimal. Children less than 18 months with stage 1-2 disease are more likely to benefit from treatment. The study of optimal radiotherapy dosage remains highly controversial." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing neuroblastoma?

"The chances, after the age of about 12.5 years, of developing neuroblastoma appear to be around 20 per 10 000. As a person gains height and weight they become more likely to develop neuroblastoma. The chances do not appear to increase significantly until the age of 5 or 6 years." - Anonymous Online Contributor

Unverified Answer

What is the latest research for neuroblastoma?

"Many different medications and research has been found to stop the tumor growth, and reduce the spread. There is still no consensus, and we wait for a new treatment option." - Anonymous Online Contributor

Unverified Answer

Is 67cu-sartate typically used in combination with any other treatments?

"We believe this review would be helpful to some pediatric oncology centers and hospitals who wish to improve the quality of care by choosing treatment modalities for patients with neuroblastoma." - Anonymous Online Contributor

Unverified Answer

What is 67cu-sartate?

"The high-density uptake in myeloid cells and bone marrow suggests a possible explanation for the clinical features of s-CMMs. S-s-Cu is effective for MR imaging, but is not a sufficient radiotherapy for the treatment of BM NBM." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of neuroblastoma?

"The primary cause of neuroblastoma is a non-hereditary genetic disorder known as neuroblastoma. This rare disorder typically affects infants who are between six months and two and a half years old. The most commonly diagnosed sites for this disease are the abdomen, the brain or nerves. Although only a few countries in the world permit testing of children, screening can identify those people in those countries who are at a higher risk of neuroblastoma later in life." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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