Trial Title:
Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma
NCT ID:
NCT05726383
Condition:
Osteogenic Sarcoma Recurrent
Conditions: Official terms:
Sarcoma
Osteosarcoma
Viscum album peptide
Conditions: Keywords:
Osteogenic
Sarcoma
Pulmonary
Metastatic
Immunotherapy
Mistletoe
Bone Tumor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Iscador*P
Description:
Iscador P given for 2 cycles with follow up imaging done every 2 cycles. If imaging is
negative patient remains on study for 13 cycles. If new lesion is found, then patient is
off study.
Arm group label:
Treatment Arm - Iscador*P
Summary:
This will be a phase II, single arm study of osteosarcoma patients with fully resected
pulmonary metastases. The MTD corresponds to the dosage recommendations of the
manufacturer of Iscador® P which is licensed in Sweden, New Zealand, South Korea, Germany
and Switzerland for the treatment of solid tumors and precancerous lesions.
The study population includes patients with relapse of osteosarcoma in the lung following
surgical resection of all gross disease (2nd or greater CR). Following completion of
final thoracotomy, they will be treated with Iscador® P at concentrations up to the MTD
with surveillance imaging via CT scan to monitor for relapsed disease.
Detailed description:
This will be a phase II, single arm study of osteosarcoma patients with fully resected
pulmonary metastases. The MTD corresponds to the dosage recommendations of the
manufacturer of Iscador® P which is licensed in Sweden, New Zealand, South Korea, Germany
and Switzerland for the treatment of solid tumors and precancerous lesions.
Iscador® P is to be injected subcutaneously (abdominal) 3 times/week. All patients will
start with Series 0 (0.01mg, 0.01mg, 0.1mg, 0.1mg, 1mg, 1mg, 1mg). If tolerated, they
will receive this series for 2 consecutive boxes (2 x 7 vials per box). This will then be
followed by Series 1 (0.1mg, 0.1mg, 1mg, 1mg, 10mg, 10mg, 10mg), which will be
administered for the following 2 consecutive boxes (2 x 7 vials per box). If tolerated,
patients will proceed to Series 2 (1mg, 1mg, 10mg, 10mg, 20mg, 20mg 20mg), which will be
continued through week 52 (13 cycles).
The study population includes patients with relapse of osteosarcoma in the lung following
surgical resection of all gross disease (2nd or greater CR). Following completion of
final thoracotomy, they will be treated with Iscador® P at concentrations up to the MTD
with surveillance imaging via CT scan to monitor for relapsed disease.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologic diagnosis of osteosarcoma.
- Patients with at least one episode of relapse in the lung (without limitation of
number of episodes), following surgical resection of all gross metastatic disease.
- Surgical resection of all possible sites of suspected pulmonary metastases in order
to achieve a complete remission within 8 weeks prior to study enrollment. Note: If
surgery related changes such as atelectasis are seen on the post-operative CT scan,
patients will remain eligible to enroll as long as the operating surgeon believes
that all sites of metastases were resected. Patients with positive microscopic
margins will be eligible to enroll.
- Pathological confirmation of metastases from at least one of the resected sites.
- Age ≥ 8 years of age and <30 years of age.
- Patients must be able to receive subcutaneous injections.
- Performance level as measured by Karnofsky ≥60% for patients > 16 years of age or
Lansky ≥ 60% for patients ≤ 16 years of age.
- Female patients of childbearing potential must have a negative serum blood pregnancy
test during screening and a negative urine pregnancy test within 3 days prior to
receiving the first dose of study drug. If the screening serum test is done within 3
days prior to receiving the first dose of study drug, a urine test is not required.
If a patient is of childbearing potential the patient must agree to use effective
contraception during the study and for 120 days after the last dose of study drug.
- If male, agrees to use an adequate method of contraception starting with the first
dose of study drug through 120 days after the last dose of study drug
- Life expectancy of > two months
- Experienced resolution of toxic effect(s) of the most recent prior anti-cancer
therapy to Grade <1 (except alopecia, cytopenia, or neuropathy). If a patient
underwent major surgery or radiation therapy of >30 Gy, they must have recovered
from the toxicity and/or complications from the intervention.
- Patients must meet the following laboratory criteria
1. Adequate hepatic function with serum aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN) and
total serum bilirubin < 2.5 times the ULN or Direct bilirubin ≤ ULN for
patients with total bilirubin levels > 2.5 X ULN
2. Absolute neutrophil count ≥ 500/dL
3. Platelet count ≥ 20,000/L
4. Creatinine ≤ 1.5 X the ULN or measurement of calculated creatinine clearance
(CrCl) ≥ 60 ml/minute
Exclusion Criteria:
- History or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the patient's
participation for the full duration of the study, or is not in the best interest of
the patient to participate, in the opinion of the treating Investigator, including,
but not limited to:
- Another known malignancy other than osteosarcoma that is progressing or
requires active treatment.
- Any prior history of other cancer within the prior 5 years with the exception
of adequately treated basal cell carcinoma or cervical intraepithelial
neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ).
- Active infection requiring systemic therapy.
- Known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
- New recurrence of osteosarcoma metastasis in any location other than lung
- Known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the study.
- Currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks of the first dose of study drug.
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
- Known active hepatitis B (e.g., hepatitis B surface antigen-reactive) or hepatitis C
(e.g., hepatitis C virus ribonucleic acid [qualitative]). Patients with past
hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence
of hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible. HBV DNA
test must be performed in these patients prior to study treatment. Patients positive
for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction
is negative for HCV RNA.
- Known history of chronic granulomatous diseases, florid autoimmune diseases,
diseases treated with immunosuppressive drugs, hyperthyroidism with tachycardia,
tuberculosis, parasitosis or Crohn's disease.
- If female, is pregnant or breastfeeding.
- Patients must have had no systemic chemotherapy or immunotherapy in the three weeks
prior to enrollment and must have fully recovered from side effects of prior
treatment at enrollment.
- Patients may not receive any additional chemotherapeutic agent (either conventional
or experimental) while on study.
- Patients must not have received radiation therapy for up to two weeks prior to
enrollment.
- Patients must have no known prior allergy to Iscador® P or any other Viscum album
products.
- Patients must not receive concomitant treatment with immunostimulant or
immunosuppressive drugs.
Gender:
All
Minimum age:
8 Years
Maximum age:
30 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sherri Mayans, RN
Phone:
551-996-2283
Email:
Sherri.Mayans@hmhn.org
Investigator:
Last name:
Katharine Offer, MD
Email:
Principal Investigator
Facility:
Name:
M.D. Anderson Children's Cancer Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Moody, MD
Phone:
713-792-2260
Email:
kmoody@mdanderson.org
Investigator:
Last name:
Karen Moody, MD
Email:
Principal Investigator
Start date:
May 14, 2024
Completion date:
May 11, 2027
Lead sponsor:
Agency:
Hackensack Meridian Health
Agency class:
Other
Collaborator:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Iscador AG, Arlesheim, Switzerland.
Agency class:
Other
Collaborator:
Agency:
Tackle Kids Cancer
Agency class:
Other
Collaborator:
Agency:
Susan Zabransky Hughes Foundation
Agency class:
Other
Source:
Hackensack Meridian Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05726383
