Is NCT07027748 recruiting in Boston, MA?

Yes, NCT07027748 is currently recruiting participants at its Boston, MA location. This neuroblastoma clinical trial is actively enrolling qualified participants.

How do I join the neuroblastoma clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Neuroblastoma Clinical Trial in Boston, MA

About This Neuroblastoma Study in Boston

This research is being done to investigate a treatment regimen of Irinotecan, Temozolomide, and Sargramostin, and an immunotherapy called Naxitamab and whether giving Naxitamab more slowly reduces the side effects for participants with relapsed or refractory neuroblastoma. The name of the study drugs involved in this study are: * Naxitamab (A type of monoclonal antibody) * Irinotecan (A standard of care chemotherapy) * Temozolomide (A standard of care chemotherapy) * Sargramostim (A standard of care, granulocyte-macrophage colony stimulating factor)

Sponsor: Steven DuBois, MD

Who Can Participate

Inclusion Criteria

Histologic Diagnosis: Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines \[i.e. \> 2 x upper limit of normal (ULN)\], at the time of initial diagnosis.

Relapsed or Refractory Disease Patients must have ONE of the following:

1\) Any prior episode of recurrent high-risk disease following completion of frontline high-risk therapy. Patients may have received other lines of therapy for treatment of recurrent disease prior to enrolling to this trial.

2\) Prior progressive high-risk disease during frontline high-risk therapy. Patients may have received other lines of therapy for treatment of progressive disease prior to enrolling to this trial.

3\) Primary resistant/refractory disease (less than partial response by INRC) detected after the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include ANBL0532, ANBL09P1, ANBL12P1, ANBL1531, ANBL2131) that was treated with additional therapy with the goal of improving remission status prior to enrolling to this trial.

Documentation of Disease: Patients must have at least ONE of the following at the time of enrollment:

1\) Measurable tumor on MRI or CT scan. Measurable is defined as ≥ 10 mm in at least one dimension (or 15 mm in short axis for lymph node) on spiral/helical CT or MRI that is MIBG avid or demonstrates increased FDG uptake on PET scan.

2\) MIBG-avid lesion detected on MIBG scan with positive uptake at a minimum of one site. This site must represent disease recurrence or known refractory disease at a site not previously radiated.

3\) In patients with known MIBG non-avid disease, FDG-avid lesion detected on FDG- PET scan with positive uptake at a minimum of one site. This site must represent disease recurrence or known refractory disease at a site not previously radiated.

Of note, patients with isolated bone marrow only disease are NOT eligible for this trial.

Prior Therapy: Prior lines of anticancer therapy allowed as described in eligibility section above by disease status. Washout periods from prior therapy are as follows:

Myelosuppressive chemotherapy: Last dose given 14 days prior to enrollment.

Small molecule targeted therapies (anti-neoplastic agents including retinoids): Last dose given 7 days prior to enrollment.

Monoclonal antibodies: Last given at least 7 days or 3 half-lives, whichever is longer, prior to enrollment.

Craniospinal irradiation: Last fraction received minimum of six weeks prior to enrollment

All other radiation: Last fraction received minimum of 14 days prior to enrollment

Hematopoietic stem cell transplant: Date of autologous stem cell infusion following myeloablative chemotherapy must have been a minimum of 12 weeks prior to enrollment. Patients are not eligible post allogeneic stem cell transplant.

Cellular therapies (including CAR-T cells, NK cells, other related cellular therapies): 21 days from the last cellular therapy infusion prior to enrollment and recovery from all associated toxicities

131I-MIBG therapy: Last therapy received a minimum of 6 weeks prior to enrollment.

Age: Patients 1 - 30 years of age at the time of enrollment are eligible for this study.

Performance level: Patients must demonstrate adequate performance level as measured by Karnofsky ≥ 70% for patients aged 16 years or older, OR Lansky ≥ 70% for patients younger than 16 years. Please see Appendix A for performance score measurement.

Participants must meet the following organ and marrow function as defined below:

Adequate bone marrow function as defined as BOTH of the following:

Peripheral absolute neutrophil count (ANC) ≥ 750/uL. Must be more than 14 days from last administration of long-acting myeloid stimulating factor (e.g. pegfilgrastim) or 7 days from last administration of short- acting myeloid stimulating factor (e.g. filgrastim or sargramostim)

Peripheral platelet count ≥ 75,000/uL. Must be without support, defined as at least 7 days from last platelet transfusion and/or platelet stimulating agent.

Adequate renal function as defined as EITHER of the following:

Radioisotope GFR ≥ 70ml/min/1.73 m2

Serum creatinine based on age/sex as follows:

Age Maximum Serum Creatinine (mg/dL)

1 to \< 2 years Male 0.6 Female 0.6

2 to \< 6 years Male 0.8 Female 0.8

6 to \< 12 years Male 1.0 Female 1.0

12 to \< 13 years Male 1.2 Female 1.2

13 to \< 16 years Male 1.5 Female 1.4 ---≥ 16 years Male 1.7 Female 1.4

The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR.

Adequate liver function defined as ALL of the following:

Total bilirubin ≤ 1.5 x ULN for age\

ALT ≤ 3.0 x ULN for age (≤ 135 U/L). For the purpose of this study, the ULN for ALT is 45 U/L

Albumin \> 3 g/dL --\*If patient has known Gilbert syndrome, direct bilirubin should be used to measure liver function instead of total bilirubin. Direct bilirubin must be within normal limits for age for these patients.

Adequate cardiac function measured by echocardiogram as defined as EITHER of the following:

Shortening fraction of ≥ 27%

Ejection fraction of ≥ 50%

Adequate blood pressure as defined by BOTH of the following:

Patients must have \< Grade 2 hypertension AND

Be on no more than one standing antihypertensive

Adequate pulmonary function: Patients must have adequate pulmonary function, defined as:

No dyspnea at rest

No exercise intolerance

Room air O2 saturation \>94%

Not on chronic oxygen therapy

Adequate pancreatic function, defined as lipase \< 1.5 x ULN

Able to comply with protocol requirements

Adequate contraception: The effects of naxitamab on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, participants with potential to become pregnant or to impregnate a partner must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a participant become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform the treating physician immediately. Patients treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of protocol therapy.

Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.

Exclusion Criteria

Chronic (more than 2 weeks duration) diarrhea \> grade 1

Prior receipt of naxitamab

Untreated central nervous system (CNS) metastatic disease

Pregnant or currently breast feeding: Pregnant participants are excluded from this study because protocol therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the parent with protocol therapy, participants planning to continue breastfeeding are excluded from the study.

Clinically significant arrhythmias, i.e. those that cause clinical symptoms or require medications for control of symptoms

Prior allergic reaction to irinotecan or temozolomide

Discontinuation of prior irinotecan or temozolomide due to unacceptable toxicity

Discontinuation of prior GD2 directed immunotherapy due to unacceptable toxicity other than allergic reaction

Serious intercurrent illness

Active uncontrolled infection

Existing major organ dysfunction CTCAE \>Grade 2, except for hearing loss and hematological status, kidney, and liver function as described in eligibility criteria

Concomitant Medication Restrictions:

Patients may not be receiving immunosuppressive medications including pharmacologic doses of glucocorticoids or immunomodulatory agents due to concern for inhibition of antibody effect. Local and inhaled steroid agents are permitted.

Patients may not be receiving concurrent anti-cancer agents or radiotherapy.

Patients may not have received valproic acid within 14 days prior to enrollment.

Patients may not have received strong CYP3A4 inducers, strong CYP3A4 inhibitors, or strong UGT1A1 inhibitors within 14 days prior to enrollment.

Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07027748) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neuroblastoma Treatment Options in Boston, MA

If you're searching for neuroblastoma treatment options in Boston, MA, this clinical trial (NCT07027748) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced neuroblastoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all neuroblastoma clinical trials near you to find additional studies recruiting in your area.

Neuroblastoma Clinical Trial in Boston, MA

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