Is NCT05304585 recruiting in Downey, CA?

Yes, NCT05304585 is currently recruiting participants at its Downey, CA location. This rhabdomyosarcoma clinical trial is actively enrolling qualified participants.

How do I join the rhabdomyosarcoma clinical trial in Downey?

To join this clinical trial in Downey, 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 Downey 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 Downey, CA

About This Rhabdomyosarcoma Study in Downey

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-

Sponsor: Children's Oncology Group

Who Can Participate

Inclusion Criteria

All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial).

Patients must be =\< 21 years at the time of enrollment.

Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients.

All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.

Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.

Patients will be eligible for the low-risk stratum (Regimen VAC/VA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.

Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients \>= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.

Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.

Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.

Patients must have a Lansky (for patients =\< 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of \>= 50. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score.

Peripheral absolute neutrophil count (ANC) \>= 750/uL (within 7 days prior to enrollment).

Platelet count \>= 75,000/uL (transfusion independent) (within 7 days prior to enrollment).

Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine (within 7 days prior to enrollment) based on age/gender as follows:

Age: 1 month to \< 6 months; Maximum serum creatinine (mg/dL): 0.4 (male) : 0.4 (female)

Age: 6 months to \< 1 year; Maximum serum creatinine (mg/dL): 0.5 (male) : 0.5 (female)

Age: 1 to \< 2 years; Maximum serum creatinine (mg/dL): 0.6 (male) : 0.6 (female)

Age: 2 to \< 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) : 0.8 (female)

Age: 6 to \< 10 years; Maximum serum creatinine (mg/dL): 1 (male) : 1 (female)

Age: 10 to \< 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) : 1.2 (female)

Age: 13 to \< 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) : 1.4 (female)

Age \>= 16 years; Maximum serum creatinine (mg/dL): 1.7 (male) : 1.4 (female)

Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and

If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \< 3 x ULN for age.

Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L.

Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L

If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \< 3 x ULN for age

Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L

All patients and/or their parents or legal guardians must sign a written informed consent.

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion Criteria

Patients who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.

Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.

Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.

Patients unable to undergo radiation therapy, if necessary, as specified in the protocol.

Evidence of uncontrolled infection.

Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.

Lactating females who plan to breastfeed their infants.

Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

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 Downey?

Yes, this clinical trial (NCT05304585) has an active research site in Downey, 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 Downey, CA

If you're searching for rhabdomyosarcoma treatment options in Downey, CA, this clinical trial (NCT05304585) 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 Downey research site is actively enrolling participants for this phase 3 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 Downey, CA

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