Indianapolis, INNCT04804007Now EnrollingIRB Ready

Germ Cell Tumor Clinical Trial in Indianapolis, IN

Access cutting-edge germ cell tumor treatment through this clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by Nabil Adra

Quick Self-Assessment

See if you qualify for this Indianapolis location

Preparing your pre-screening questions…

Expert Care in Indianapolis

Access germ cell tumor specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related germ cell tumor treatment provided free

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Check if you qualify for this germ cell tumor clinical trial in Indianapolis, IN

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Germ Cell Tumor Study in Indianapolis

This is an open label randomized phase II trial of maintenance oral etoposide vs. observation in patinets with relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT).

Sponsor: Nabil Adra

Who Can Participate

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information
Age ≥ 18 years at the time of consent
Histological or serological evidence of non-seminomatous GCT
Relapsed disease after first-line cisplatin-based combination chemotherapy
Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines
HDCT must have been used as the initial salvage chemotherapy regimen (2nd line therapy) 6.1. Note: 1 or 2 cycles of standard course regimens prior to HDCT are acceptable (regimens include VeIP \[vinblastine+ifosfmaide+cisplatin\] or TIP \[paclitaxel+ifosfamide+cisplatin\] or PVB \[cisplatin+vinblastine+bleomycin\]
Normal or declining tumor markers (AFP and hCG) at time of screening
Adverse events from prior therapy recovered to CTCAE v5.0 grade ≤ 2 at time of registration
Women with ovarian germ cell tumors are eligible
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 28 days of study registration
Last dose of HDCT must be ≤16 weeks from study registration
Adequate organ function lab values obtained within 28 days prior to study registration System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,000 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥8 g/dL Renal Serum creatinine \<2mg/dL Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR
5 X ULN for subjects with liver metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
If a female of childbearing potential, a negative urine pregnancy test within 28 days prior to receiving the first dose of study drug. o Non-childbearing potential is defined as (by other than medical reasons):
≥ 45 years of age and has not had menses for \>2 years
Amenorrheic for \< 2 years without a hysterectomy and/or oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation
Post hysterectomy or oophorectomy. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound.
For female patients of childbearing potential and male patients, agreement (by patient and/or partner) to use two forms of highly effective contraception (i.e., one that results in a low failure rate \[\< 1% per year\] when used consistently and correctly) starting with the first dose of study therapy and to continue its use for 30 days after the last dose of study therapy, or abstain from heterosexual activity.

Exclusion Criteria

Relapsed pure seminoma
Rising tumor markers (AFP and hCG) at time of screening
Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) \>16 weeks ago
Treatment with any investigational agent within 28 days prior to study registration
Other active malignancy requiring treatment in past 12 months
History of psychiatric illness or social situations that would limit compliance with study requirements
Active infection requiring systemic therapy
Previous hypersensitivity to etoposide which did not recover with supportive care
Pregnancy, lactation, or breastfeeding
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

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 Indianapolis?

Yes, this clinical trial (NCT04804007) has an active research site in Indianapolis, IN 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.

Germ Cell Tumor Treatment Options in Indianapolis, IN

If you're searching for germ cell tumor treatment options in Indianapolis, IN, this clinical trial (NCT04804007) 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 Indianapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced germ cell tumor 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 germ cell tumor clinical trials near you to find additional studies recruiting in your area.

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