MIBG Therapy for Patients With MIBG Avid Tumors

  • STATUS
    Recruiting
  • End date
    Mar 3, 2022
  • participants needed
    65
  • sponsor
    Nationwide Children's Hospital
Updated on 3 June 2021

Summary

This is a Phase II study for patients with MIBG avid tumors. The study is to determine the response rate to <131>I-MIBG in patients with de novo, relapsed or refractory neuroblastoma or other MIBG avid malignant tumors 42 days post MIBG therapy. It will also be evaluating the tolerability and safety of the study agent by evaluating the hematopoietic and non-hematopoietic toxicity of <131>I-MIBG therapy. Tumor response will be evaluated by comparing the patient's disease pre-treatment against the patient's day +42 post <131>I-MIBG treatment. The evaluations may include the following: <131>I-MIBG scan, CT or MRI, urine catecholamine, bone marrow analyses and any other tests considered standard of care for cancer evaluation. To be eligible for participation, patients must have tumors that are MIBG avid. Patients must also have a stem cell source for autologous rescue in the event of protracted therapy associated cytopenias. Peripheral stem cell collections are preferred as the hematopoietic cell source. Bone marrow harvests for a hematopoietic cell source is an alternative. This study will provide data for future clinical trials utilizing <131>I-MIBG therapies. A room on H12 has been prepared with lead lined walls, and many radiation safety components to accomodate this treatment. <131>I metaiodobenzlguanidine (<131>I-MIBG) is a radiopharmaceutical that concentrates within adrenomedullary tissue. The agent was initially used for tumor imaging due to its capability to locate pheochromocytomas, neuroblastomas and other neuroendocrine tumors. <131>I-MIBG was subsequently used as an therapeutic agent for these tumor types. Phase I and II therapeutic trials targeting neuroblastoma have reported response rates of 10-50%. Toxicities observed have been mainly hematopoietic, with ~50% of patients receiving 15mCi/kg requiring stem cell reinfusion. Observed non-hematopoietic toxicities have been mild. Most recently, trials have been conducted combining the study agent with myeloablative chemotherapy and stem cell reinfusion have been performed with initial response rates of ~50%.

Details
Condition MIBG Avid Tumors
Treatment MIBG
Clinical Study IdentifierNCT02378428
SponsorNationwide Children's Hospital
Last Modified on3 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must be between 12 months and 65 years at the time of enrollment
Diagnosis: diagnosis of neuroblastoma or at the time of relapse by histology and/or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
Disease Status
The presence of refractory or progressive disease (PD)
For patients with neuroblastoma, the presence of mixed response (MR), or no response (NR) following the completion of A3973 or equivalent induction therapy, or the presence of a partial response (PR) with high Curie score (>2) following induction therapy
Patients with de novo high risk neuroblastoma who have completed standard induction therapy and do not achieve a CR, VGPR, or PR with low Curie score post induction
Patients must have evidence of MIBG avid disease as determined by diagnostic MIBG scan obtained within 4 weeks of study entry
Patients who receive greater than 12 mCi/kg are required to have stem cell rescue products harvested prior to study treatment
Performance Level and Life Expectancy: Patients must have a Lansky Play Scale17 of 60% (<16 yrs old), Karnofsky score 60% (>16 yrs old), or ECOG score of < or equal to 2 and a life expectancy of 2 months
Patients may enter this study with or without salvage therapy for recurrent tumor. Patients must have fully recovered from the toxic effects of any prior therapy
Organ Function requirements
Hematopoietic Criteria
Hemoglobin- 10 gl/dl (transfusion allowed)
ANC- 550 / cu mm (off myeloid growth factors)
Platelets- > 50,000/cu mm. (transfusion allowed - however patients must not require more than two platelet transfusions per week)
Renal Function
Serum Creatinine- < 2 x ULN for age
Hepatic Function
Total bilirubin <1.5 x ULN for age SGPT (ALT) and SGOT (AST) < 10 x ULN for
age
Cardiac Function
For children with NBL: Normal ejection fraction (>55%) documented by
echocardiogram or radionuclide MUGA evaluation OR normal fractional shortening
(>27%) documented by echocardiogram
For subjects with paraganglioma/ pheochromocytoma: No clinically significant
cardiac dysfunction
Pulmonary Function
Patients must have clinically normal lung function as manifested by no dyspnea
at rest and no oxygen requirement
Reproductive Function
Females of childbearing potential must have a negative pregnancy test within 1 week prior to treatment with 131I-MIBG
Patients of childbearing potential must agree to use an effective birth control method
Female patients who are lactating must agree to stop breast feeding

Exclusion Criteria

Pregnancy or breast feeding
Have undergone a prior allogeneic BMT
Patients with disease of any major organ system that would compromise their ability to withstand therapy. Any significant organ impairment should be discussed with the Study Chair prior to patient entry
Patients who are on hemodialysis
Hepatitis B surface antigen (+) or Hepatitis C positive in preceding six months
Patients with an active infection requiring intravenous antivirals, antibiotics or antifungals. Patients on prolonged antifungal therapy are still eligible if they are culture negative and biopsy negative in suspected residual radiographic lesions have stabilized or regressed and they meet other organ function criteria
Prior total body irradiation, prior total abdominal or whole liver radiation
Any medical or psychological condition or situation deemed by the PI to put the patient at increased risk of complications or noncompliance
Patients with curative treatment options
Patients for whom busulfan/ melphalan consolidation therapy following treatment with 131I-MIBG is planned
Patients for who CEM (carboplatin, etoposide, melphalan) therapy is administered within 30 days prior to 131I-MIBG therapy or for whom this therapy is planned within 30 days following administration of 131I-MIBG
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note