MIBG Therapy for Patients With MIBG Avid Tumors
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any - 40 |
| Updated: | 4/27/2018 |
| Start Date: | March 2014 |
| End Date: | March 2020 |
| Contact: | Melinda Triplet, RN |
| Email: | melinda.triplet@nationwidechildrens.org |
| Phone: | 614-722-6039 |
A Phase II Study of <131>I-Metaiodobenzyguanidine (<131>I-MIBG) Therapy for Patients With MIBG Avid Tumors
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%.
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%.
Inclusion Criteria:
-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)
- 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.
- 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.
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.
- Patients with known MIBG avid brain metastasis.
We found this trial at
1
site
700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Mark A Ranalli, MD
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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