Is NCT06023641 recruiting in Palo Alto, CA?

Yes, NCT06023641 is currently recruiting participants at its Palo Alto, CA location. This rhabdomyosarcoma clinical trial is actively enrolling qualified participants.

How do I join the rhabdomyosarcoma clinical trial in Palo Alto?

To join this clinical trial in Palo Alto, 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 Palo Alto 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.

Rhabdomyosarcoma Clinical Trial in Palo Alto, CA

About This Rhabdomyosarcoma Study in Palo Alto

This is a phase II study to determine safety and efficacy of combining liposomal irinotecan with vincristine alternating with VAC in intermediate-risk patients, liposomal irinotecan with temozolomide and vincristine alternating with VAC in high-risk patients and the chemotherapy combinations when given with concomitant radiation therapy in intermediate and high risk patients. Primary Objective * Estimate event-free survival for intermediate-risk participants treated with VAC and vincristine an

Sponsor: St. Jude Children's Research Hospital

Who Can Participate

Inclusion Criteria

• Newly diagnosed participants with the diagnosis of rhabdomyosarcoma (RMS) of any subtype. This includes embryonal rhabdomyosarcoma (fusion negative), alveolar rhabdomyosarcoma (fusion positive), as well as spindle cell and sclerosing • Must have either low-, intermediate-risk or high-risk disease, defined as:

Low-risk: TP53 and MYOD1 negative AND • Embryonal, congenital/infantile spindle cell, or spindle cell/sclerosing FOXO1 fusion negative histology

Stage 1 Group I, Group II

Stage 1 Group III orbital only

Stage 2 Group I, Group II

Intermediate-risk: MYOD1 and TP53 negative AND • Embryonal, congenital/infantile spindle cell, or spindle cell/sclerosing FOXO1 fusion negative histology o Stage 1 Group III non orbit o Stage 3 Group I/II o Stage 2/3 Group III

Stage 4 Group IV and Oberlin 0-1 • Alveolar, spindle cell/sclerosing FOXO1 fusion positive histology

Stage 1-3, Group I-III N0

High-risk: All MYOD1 and TP53 mutant tumors regardless of stage and Group AND/OR

Embryonal, congenital/infantile spindle cell or spindle cell/sclerosing FOXO1 fusion negative o Group IV ≥ 10 year of age and Oberlin ≥ 2

Alveolar, spindle cell/sclerosing FOXO1 fusion positive

Stage 4 Group IV See Appendices I and II for Staging and Clinical Grouping. Age \< 22 years (eligible for enrollment until 22nd birthday) • Performance level corresponding to ECOG score of 0, 1, or 2. The Lansky performance score should be used for participants \< 16 years (see Appendix VII).

Participant has received no prior radiotherapy or chemotherapy for rhabdomyosarcoma (excluding steroids) unless an emergency situation requires local tumor treatment (discuss with PI).

Initiation of chemotherapy is planned within 6 weeks (42 days) of the definitive biopsy or surgical resection.

Adequate bone marrow function defined as:

Peripheral absolute neutrophil count (ANC) ≥ 750/μL

Platelet count ≥ 75,000/μL (transfusion independent)

Adequate liver function defined as total bilirubin \< 1.5 x upper limit of normal (ULN) for age. Participants with biliary or hepatic primaries with bilirubin values greater than 1.5 x ULN may be enrolled on study if all other eligibility criteria are met. Adequate renal function defined as: Creatinine clearance or radioisotope GFR \> 70 mL/min/1.732 or serum creatinine based on age as follows: Age Maximum serum creatinine (mg/dL) Male Female 1 month to \< 6 months 0.4 0.4 6 months to \< 1 year 0.5 0.5 Age Maximum serum creatinine (mg/dL)

to \< 2 years 0.6 0.6

to \< 6 years 0.8 0.8 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4 \> 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR25 utilizing child length and stature. Data published by the CDC. Participants with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract. • Adequate pulmonary function defined as: no evidence of dyspnea at rest and a pulse oximetry \> 94% if there is a clinical indication for determination. Pulmonary function tests are not required. • Patients requiring emergency radiation therapy are eligible for enrollment on this trial. See Section 4.11 for radiation therapy guidelines. • No evidence of active, uncontrolled infection. All participants and/or their parents or legal guardians must sign a written informed consent.

Exclusion Criteria

• Patients who have received any chemotherapy (excluding steroids). • Patients who have received prior full course RT at the primary site of disease. This does not exclude patients that received emergent radiation.

Ongoing or history of non-infectious interstitial lung disease requiring significant medical intervention.

Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for at least 3 months after treatment is completed.

Female patients who are pregnant are not eligible since fetal toxicities or teratogenic effects have been noted for several of the study drugs. Female participants \> 10 years of age or post-menarchal must have a negative serum or urine pregnancy test within 24 hours prior to beginning treatment.

Lactating females who are or plan to breastfeed their infants are not eligible.

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 Palo Alto?

Yes, this clinical trial (NCT06023641) has an active research site in Palo Alto, CA 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.

Rhabdomyosarcoma Treatment Options in Palo Alto, CA

If you're searching for rhabdomyosarcoma treatment options in Palo Alto, CA, this clinical trial (NCT06023641) 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 Palo Alto research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced rhabdomyosarcoma 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 rhabdomyosarcoma clinical trials near you to find additional studies recruiting in your area.

Rhabdomyosarcoma Clinical Trial in Palo Alto, CA

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